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Sybron Dental Specialties, Inc.

Also registered as Sybron Dental Specialties

United StatesFDA applicant, unverified

Devices
121
FDA recalls
21

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 51-100 of 121

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  • Belleglass Hp Dc Opaceous Dentin Lcte 2 Ref K013009

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

  • Nexus 2 Clear Ref K013609

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

  • Connect Ref K954689

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

  • Life Fast Set, Life Regular Set Ref K150559

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

  • Supertorque High-Speed Handpieces And Gentlepower Handpieces And Attachements Ref K073478

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

  • SonicFill 2 Ref K143209

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

  • Prodigy Ac Ref K963805

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

  • System 1 Ref K940845

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

  • Enlight Lv Ref K984362

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

  • Prodigy 2 Ref K982148

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

  • Tempbond Clear With Triclosan Ref K053565

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

  • Herculite Xr & Xrv Ref K943642

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

  • Solo Plus Ortho Ref K990252

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

  • Envision Ref K032042

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

  • Belleglashp Ref K955331

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

  • Tempfil F - 2 Ref K982459

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

  • Optibond 2A Precoat Ref K955068

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

  • Nexus Ref K954762

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

  • Tempfil Ref K013895

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

  • Corerestore 2 Ref K011798

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

  • B-System Silicone Ref K982917

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

  • Demetron A.2 Ref K063116

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

  • Solo Ortho 2 Ref K994309

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

  • Improved Try-In Gel Ref K001899

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

  • D3 Chroma Ref K042422

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

  • Kerr Hard Denture Reline Material Ref K981448

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

  • Touch N' Heat Ref K963862

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

  • Apex Finder Models 7005 Ref K962803

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

  • Pulp Canal Sealer, Pulp Canal Sealer EWT Ref K152956

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

  • Sealite Fl Ref K954827

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

  • Foundation Indirect Composite Resin Ref K970495

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

  • Premise Ref K032921

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

  • Optibond All-In-One Ref K060469

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

  • Sealapex Ref K944480

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

  • Spirit Mb Ref K943245

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

  • Solo Ortho 3 Ref K020502

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

  • Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes Ref K152959

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

  • Miniendo Iii Ref K003640

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

  • Prodigy 4 Translucent Shades Ref K992118

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

  • Ormco Spark Aligner System Ref K182826

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

  • Point 4 Translucent Modified Ref K013529

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

  • Enlight-2 Ref K984217

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

  • Prodigy- 3 Ref K983370

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

  • Expasyl Power Applicator Ref K051933

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

  • Kerr Compomer Ref K974105

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

  • Take 1 Advance Ref K130869

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

  • Smearclear Ref K024198

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

  • Century Model 105C Ref K093341

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

  • Fill-In Ref K031476

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

  • Kerr Vps Impression Material Ref K050604

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

Rows 51-100 of 121

Showing 51-100 of 121

FDA recalls21

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 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