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Sybron Dental Specialties, Inc.

Also registered as Sybron Dental Specialties

United StatesFDA applicant, unverified

Devices
121
FDA recalls
21

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sybron Dental Specialties, Inc. makes

Sybron Dental Specialties, Inc. manufactures dental adhesives, restorative materials, and irrigation systems. Their portfolio includes bonding agents like OptiBond Solo Plus, flowable composites such as Point 4 Flowable, and temporary restorative cements like Temp-Bond NE 2. The company also produces dental etchant (Kerr Gel Etchant), dental burs (e.g., Shaping Hedström N.T.), and irrigation devices like the Quantec-E Irrigation System 2. Additional offerings include dental sealants (Sealapex 4), universal adhesives (Prodigy 4), and modified endodontic instruments (Extrude Modified).

These devices are regulated under the FDA’s 510(k) pathway, with classifications spanning Class I, Class II, and unclassified (U). The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue121

Newest first, rows 1-50 of 121

Search and filter all 121 devices
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  • Prodigy 4 Ref K990898

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kerr Gel Etchant Ref K000954

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sealapex 4 Ref K010940

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Point 4 Flowable Ref K012321

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Temp-Bond Ne 2 Ref K003658

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Extrude Ref K940379

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optibond Solo Plus Ref K990498

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Quantec-E Irrigation System 2 Ref K992195

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Revolution Formula 2 Ref K013647

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nexus Universal, Nexus Universal Chroma Ref K151332

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Prodigy Ref K944659

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vectors Temporary Anchorage System Ref K061230

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Extrude Modified Ref K012405

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Shaping Hedstrom N.T. Ref K953604

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modification To Kavo Quattrocare Ref K071288

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Silane Primer Ref K954708

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optiguard Ref K945539

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Steri-Cassette and Steri-Cage Sterilization Packaging System Ref K162063

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sybraloy Ref K940675

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fixafloss Ref K071615

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Belleglass Hp Enamel 2 Ref K013007

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Belleglass Hp Opaceous Dentin Ref K000269

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Herculite Ultra Ref K082671

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optiband Lc Ref K032407

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Quantec-E Endo System Ref K990739

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nexus 2 Ref K992160

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tempfil C&B Ref K964981

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Belleglass Hp Enamel Ref K000530

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nexus 2 Modified Ref K013008

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Linglock Ref K061042

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Damon Ft Ref K032408

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endo Analyzer, Model 8005, Modified Ref K990225

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Quantec-E Irrigation System Ref K991035

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Life 2 Ref K012717

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Removable Arylic Herbst, Allesee Snore Appliance (Asa), And Enoch Snorinator Ref K070327

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optibond-D Ref K943738

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Take 1 Ref K003808

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Life Ref K944416

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zone, ZoneFree, Zone A1 Ref K151526

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kerr Nexus One Bottle Adhesive Ref K972858

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sealapex Ref K972369

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endo Analyzer, Model 8005 Ref K973439

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Soft Denture Rebasing Resin Ref K963736

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tubli-Seal Ewt Ref K942393

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Try-In Gel Ref K954643

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Life And Life Fast Set Ref K961708

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optibond 2 Ref K012322

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sonicflex 2003 And Sonicflex Lux 2003 L With Instrument Tips Ref K080089

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sonicfill 2010 Ref K091091

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Belleglass Hp Translucent Dentin Ref K000436

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 121

Showing 1-50 of 121

FDA recalls21

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 21 recalls initiated by Sybron Dental Specialties, Inc., the earliest on 2003-02-25 and the most recent on 2015-02-11. By recorded status: 21 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 21 recalls.

  • 2015

    • 11 Feb 2015 Z-1291-2015 Class II Terminated Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination. Distribution: Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan, Submission number: K962288

  • 2013

    • 6 Jun 2013 Z-2195-2013 Class II Terminated The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly. Distribution: Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.

  • 2011

    • 3 Mar 2011 Z-0989-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain. Submission number: K052106
    • 3 Mar 2011 Z-0990-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain. Submission number: K052106

  • 2010

    • 4 Nov 2010 Z-1146-2012 Unclassified (pre-2012) Terminated Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker. Distribution: Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN,…
      Full distribution text Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.
      Submission number: K914178
    • 22 Oct 2010 Z-1000-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
      Submission number: K052106
    • 22 Oct 2010 Z-1005-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
      Submission number: K052106
    • 22 Oct 2010 Z-1006-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
      Submission number: K052106
    • 22 Oct 2010 Z-1007-2012 Unclassified (pre-2012) Terminated The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
      Submission number: K052106

  • 2009

    • 24 Aug 2009 Z-1150-2010 Unclassified (pre-2012) Terminated Some of the material has been found to be gelled and therefore becomes unusable. Distribution: Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand. Submission number: K973388
Show all 21 recalls

  • 2009

    • 23 Feb 2009 Z-0916-2010 Unclassified (pre-2012) Terminated Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card. Distribution: Nationwide distribution Submission number: K082671
    • 23 Feb 2009 Z-0917-2010 Unclassified (pre-2012) Terminated Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal. Distribution: Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain,…
      Full distribution text Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.
      Submission number: K040940

  • 2008

    • 14 Nov 2008 Z-0151-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0152-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0153-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0154-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0155-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0156-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0157-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055
    • 14 Nov 2008 Z-0158-2010 Unclassified (pre-2012) Terminated The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. Distribution: Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland,…
      Full distribution text Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
      Submission number: K834055

  • 2003

    • 25 Feb 2003 Z-0712-03 Unclassified (pre-2012) Terminated Moisture ingress into packaging of test strips may cause premature failure. Distribution: Nationwide and Canada. Submission number: K922481

Frequently asked questions

How many devices does Sybron Dental Specialties, Inc. have in the registry?

The registry currently lists 121 devices for Sybron Dental Specialties, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sybron Dental Specialties, Inc.'s devices?

Among its 50 most recently registered devices, Sybron Dental Specialties, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Sybron Dental Specialties, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Sybron Dental Specialties, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sybron Dental Specialties, Inc.?

FDA recall records list 21 recalls initiated by Sybron Dental Specialties, Inc., the most recent initiated on 11 Feb 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sybron Dental Specialties, Inc. in the registry?

The most recently registered devices listed for Sybron Dental Specialties, Inc. include PRODIGY 4, KERR GEL ETCHANT, SEALAPEX 4 and POINT 4 FLOWABLE.

Generated automatically from registry data and not verified by a human reviewer.