Company ยท US
Sybron Dental Specialties, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2018. Name variants (Inc, Corp, punctuation) are merged.
121510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 35 |
| EMA | Cement, Dental | 14 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 12 |
| ELW | Material, Impression | 11 |
| KLE | Agent, Tooth Bonding, Resin | 10 |
| EKC | Excavator, Dental, Operative | 8 |
| KIF | Resin, Root Canal Filling | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 6 |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 |
| EAT | Tester, Pulp | 4 |
| DYW | Bracket, Plastic, Orthodontic | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 |
| EFB | Handpiece, Air-Powered, Dental | 2 |
| EIA | Unit, Operative Dental | 2 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EEF | Clamp, Rubber Dam | 1 |
| EJJ | Alloy, Amalgam | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 11, 2018 | K182826 | Ormco Spark Aligner System Sybron Dental Specialties | NXC |
| Apr 21, 2017 | K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System Sybron Dental Specialties | KCT |
| Aug 5, 2016 | K160097 | Image Fast Set, Image Regular Set Sybron Dental Specialties | ELW |
| Jul 27, 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress Sybron Dental Specialties | KIF |
| May 6, 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT Sybron Dental Specialties | KIF |
| Apr 14, 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes Sybron Dental Specialties | KIF |
| Sep 10, 2015 | K151526 | Zone, ZoneFree, Zone A1 Sybron Dental Specialties | EMA |
| Aug 17, 2015 | K151332 | Nexus Universal, Nexus Universal Chroma Sybron Dental Specialties | EMA |
| Jun 19, 2015 | K150559 | Life Fast Set, Life Regular Set Sybron Dental Specialties | EJK |
| Feb 5, 2015 | K143209 | SonicFill 2 Sybron Dental Specialties | EBF |
| May 30, 2013 | K130869 | TAKE 1 ADVANCE Sybron Dental Specialties | ELW |
| Apr 5, 2010 | K093341 | CENTURY MODEL 105C Sybron Dental Specialties, Inc. | EFB |
| Oct 14, 2009 | K091091 | SONICFILL 2010 Sybron Dental Specialties, Inc. | EBF |
| Dec 11, 2008 | K082671 | HERCULITE ULTRA Sybron Dental Specialties | EBF |
| Sep 4, 2008 | K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS Sybron Dental Specialties, Inc. | ELC |
| Sep 3, 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS Sybron Dental Specialties, Inc. | EFB |
| Sep 21, 2007 | K071615 | FIXAFLOSS Sybron Dental Specialties, Inc. | EEF |
| Jul 19, 2007 | K071288 | MODIFICATION TO KAVO QUATTROCARE Sybron Dental Specialties, Inc. | EBF |
| May 25, 2007 | K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR Sybron Dental Specialties, Inc. | LRK |
| Jan 19, 2007 | K061042 | LINGLOCK Sybron Dental Specialties | DYW |
| Dec 5, 2006 | K063116 | DEMETRON A.2 Sybron Dental Specialties | EBZ |
| Aug 3, 2006 | K061230 | VECTORS TEMPORARY ANCHORAGE SYSTEM Sybron Dental Specialties | OAT |
| Mar 28, 2006 | K060469 | OPTIBOND ALL-IN-ONE Sybron Dental Specialties, Inc. | KLE |
| Feb 3, 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN Sybron Dental Specialties, Inc. | EMA |
| Jan 3, 2006 | K051933 | EXPASYL POWER APPLICATOR Sybron Dental Specialties, Inc. | ELW |
| Apr 15, 2005 | K050604 | KERR VPS IMPRESSION MATERIAL Sybron Dental Specialties, Inc. | ELW |
| Nov 15, 2004 | K042422 | D3 CHROMA Sybron Dental Specialties, Inc. | DYH |
| Jul 21, 2004 | K041474 | MAXCEM Sybron Dental Specialties, Inc. | EMA |
| Nov 13, 2003 | K032921 | PREMISE Sybron Dental Specialties, Inc. | EBF |
| Oct 15, 2003 | K032408 | DAMON FT Sybron Dental Specialties, Inc. | DYW |
| Oct 6, 2003 | K032407 | OPTIBAND LC Sybron Dental Specialties, Inc. | DYH |
| Sep 29, 2003 | K032042 | ENVISION Sybron Dental Specialties, Inc. | DYH |
| Jul 2, 2003 | K031476 | FILL-IN Sybron Dental Specialties, Inc. | EBG |
| Mar 5, 2003 | K024198 | SMEARCLEAR Sybron Dental Specialties, Inc. | KJJ |
| Jun 27, 2002 | K021797 | L.E.DEMETRON Sybron Dental Specialties, Inc. | EBZ |
| May 1, 2002 | K020502 | SOLO ORTHO 3 Sybron Dental Specialties, Inc. | DYH |
| Mar 29, 2002 | K020267 | OPTILUX CURING LIGHTS Sybron Dental Specialties, Inc. | EBZ |
| Feb 4, 2002 | K013895 | TEMPFIL Sybron Dental Specialties, Inc. | EBG |
| Jan 18, 2002 | K013510 | POINT 4 MODIFIED Sybron Dental Specialties, Inc. | EBF |
| Jan 16, 2002 | K013647 | REVOLUTION FORMULA 2 Sybron Dental Specialties, Inc. | EBF |
| Jan 16, 2002 | K013609 | NEXUS 2 CLEAR Sybron Dental Specialties, Inc. | EMA |
| Jan 9, 2002 | K013529 | POINT 4 TRANSLUCENT MODIFIED Sybron Dental Specialties, Inc. | EBF |
| Oct 25, 2001 | K012717 | LIFE 2 Sybron Dental Specialties, Inc. | EJK |
| Oct 3, 2001 | K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 Sybron Dental Specialties, Inc. | EBF |
| Oct 2, 2001 | K013008 | NEXUS 2 MODIFIED Sybron Dental Specialties, Inc. | EMA |
| Oct 1, 2001 | K013007 | BELLEGLASS HP ENAMEL 2 Sybron Dental Specialties, Inc. | EBF |
| Sep 20, 2001 | K012082 | OPTIBOND SOLO PLUS ACTIVATOR Sybron Dental Specialties, Inc. | KLE |
| Sep 4, 2001 | K012405 | EXTRUDE MODIFIED Sybron Dental Specialties, Inc. | ELW |
| Aug 30, 2001 | K012322 | OPTIBOND 2 Sybron Dental Specialties, Inc. | KLE |
| Aug 27, 2001 | K012321 | POINT 4 FLOWABLE Sybron Dental Specialties, Inc. | EBF |
Newest 50 of 121.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2015 | Sybron Dental Specialties Outer cardboard box labeling:
Pinnacle Cure Sleeve, Curing Light Tip Sleeves.
Kerr Total Care.
Part Number: 4513C or 4513-1
Single Patient Use
Fits 13mm Tips. Pack of 400.
Metrex Research, Manufa Terminated |
MMP | K962288 |
| Sep 12, 2013 | Sybron Dental Specialties AOA Mini RPE Screw Assembly , a component of
Herbst, MARA and Fixed Metal devices.
Product Usage:
AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functio Terminated |
DYJ | None listed |
| Mar 2, 2012 | Sybron Dental Specialties Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. Terminated |
ELW | K914178 |
| Feb 13, 2012 | Sybron Dental Specialties Flow Tec Part Number 3786-754, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age Terminated |
EBF | K052106 |
| Feb 13, 2012 | Sybron Dental Specialties Flow Tec Part Number 3784-514, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age Terminated |
EBF | K052106 |
| Feb 13, 2012 | Sybron Dental Specialties Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variet Terminated |
EBF | K052106 |
| Feb 13, 2012 | Sybron Dental Specialties Artiste Flowable Part Number N28A, Syringe Lot Number 165741
The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding Terminated |
EBF | K052106 |
| Feb 11, 2012 | Sybron Dental Specialties Flow Tec Nano-Hybrid Flowable Affected Product
Syringe Part No. Value Pack Part. No. Shade
BEN3784-514 BEN3786-754 A1
BEN3784-532 BEN3786-763 A2
BEN3784-541 BEN3784-738 A3
BEN3784-550 BEN3784-747 A3. Terminated |
EBF | K052106 |
| Feb 11, 2012 | Sybron Dental Specialties Artiste Nano-Hybrid Affected Product.
Syringe Part No. Value Pack Part. No Shade
N28A N28VA A1
N28B N28VB Terminated |
EBF | K052106 |
| Mar 16, 2010 | Sybron Dental Specialties Bond-1 Primer/Adhesive.
The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bondi Terminated |
KLE | K973388 |
| Mar 2, 2010 | Sybron Dental Specialties Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA.
Intended as a root canal filling material that is used in conjunction with gutta percha Terminated |
KIF | K040940 |
| Mar 2, 2010 | Sybron Dental Specialties Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. Terminated |
EBF | K082671 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/5 SCHE Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/3 SCHE Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/0 SCHE Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/0-6 Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/4 Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/2 Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/1 Terminated |
EKC | K834055 |
| Nov 9, 2009 | Sybron Dental Specialties Neos Vanadium Excavator Part Number 591/0 Terminated |
EKC | K834055 |
| Apr 9, 2003 | Sybron Dental Specialties Gluteraldehyde Concentration Indicators.
MetriTest 1.5% and MetriTest 1.8%, also
OmniChek 1.5% and OmniCheck 1.8% Terminated |
JOJ | K922481 |