Sybron Dental Specialties
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 121
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1291-2015 | Class II | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. | February 11, 2015 |
| Z-2195-2013 | Class II | AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage | June 6, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182826 | Ormco Spark Aligner System | October 11, 2018 |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | April 21, 2017 |
| K160097 | Image Fast Set, Image Regular Set | August 5, 2016 |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | July 27, 2016 |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | May 6, 2016 |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | April 14, 2016 |
| K151526 | Zone, ZoneFree, Zone A1 | September 10, 2015 |
| K151332 | Nexus Universal, Nexus Universal Chroma | August 17, 2015 |
| K150559 | Life Fast Set, Life Regular Set | June 19, 2015 |
| K143209 | SonicFill 2 | February 5, 2015 |
| K130869 | TAKE 1 ADVANCE | May 30, 2013 |
| K093341 | CENTURY MODEL 105C | April 5, 2010 |
| K091091 | SONICFILL 2010 | October 14, 2009 |
| K082671 | HERCULITE ULTRA | December 11, 2008 |
| K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | September 4, 2008 |
| K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | September 3, 2008 |
| K071615 | FIXAFLOSS | September 21, 2007 |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | July 19, 2007 |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | May 25, 2007 |
| K061042 | LINGLOCK | January 19, 2007 |