Skip to content

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 101-121 of 121

Search and filter all 121 devices
Skip device list

  • Kolor + Ref K961284

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

  • Tempfil F Ref K963786

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

  • Optibond Solo Plus 2 Ref K991808

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

  • Maxcem Ref K041474

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

  • Calcium Hydroxide Medicament Ref K964191

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

  • Tubli-Seal, Tubli-Seal EWT, Tubli-Seal Xpress, Tubli-Seal EWT Xpress Ref K153067

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

  • Optibond Solo Plus Activator Ref K012082

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

  • Enlight (Tentative Name) Ref K972890

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

  • Belleglass Hp Enamel Repair Material Ref K971762

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

  • Image Fast Set, Image Regular Set Ref K160097

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

  • Improved Enlight Lv Ref K001881

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

  • Titanium Bird Beak Plier Ref K955242

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

  • Point 4 Modified Ref K013510

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

  • Take 1 Bite Ref K001876

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

  • L.e.demetron Ref K021797

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

  • System B Heat Source Ref K970715

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

  • Permlastic 3 Ref K003650

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

  • Tempbond Clear-2 Ref K982590

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

  • Solo Ortho Ref K990743

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

  • Pulp Canal Sealer Ewt Ref K945244

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

  • Optilux Curing Lights Ref K020267

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

Rows 101-121 of 121

Showing 101-121 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