Kerr Corporation
FDA Regulatory Profile
Kerr Corporation appears in FDA public data with 5 recalls, 32 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1788-2014, Class II) was initiated on May 29, 2014. Its most recent 510(k) clearance was granted on January 7, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 32
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1788-2014 | Class II | Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended | May 29, 2014 |
| Z-0401-2013 | Class II | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Gr | October 25, 2012 |
| Z-0414-2013 | Class II | The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupe | April 10, 2012 |
| Z-0268-2013 | Class II | The brand name of the device is AlgiNot, a dental impression material. Product | February 21, 2012 |
| Z-0402-2013 | Class II | Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Num | November 17, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252890 | ZenSeal Pro | January 7, 2026 |
| K222830 | Rainbow 360 | January 12, 2023 |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | August 31, 2022 |
| K191548 | Nexus Universal Self-Cure | October 11, 2019 |
| K182162 | OptiBond eXTRa Universal | November 7, 2018 |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | August 8, 2017 |
| K163064 | Demi Ultra | July 18, 2017 |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate | February 3, 2017 |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | January 13, 2017 |
| K162436 | EndoVac Pure | December 21, 2016 |
| K162257 | P1145 Dental Restorative | November 7, 2016 |
| K160441 | Identic and KromaFaze Alginate Dental Impression Materials | June 30, 2016 |
| K123468 | DEMI ULTRA | March 20, 2013 |
| K123595 | NEXUS RMGI | February 19, 2013 |
| K110747 | TEMPFLEX | June 14, 2011 |
| K110092 | TAKE 1 ADVANCED RIGID TRAY | April 8, 2011 |
| K102621 | SOLSTICE | January 28, 2011 |
| K103351 | DMC COMPOSITE 2 | January 20, 2011 |
| K101756 | TSC | October 26, 2010 |
| K102163 | REALSEAL XT SEALER | October 16, 2010 |