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Kerr Corporation

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
32
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1788-2014Class IITytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended May 29, 2014
Z-0401-2013Class IIBioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone GrOctober 25, 2012
Z-0414-2013Class IIThe brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser LoupeApril 10, 2012
Z-0268-2013Class IIThe brand name of the device is AlgiNot, a dental impression material. Product February 21, 2012
Z-0402-2013Class IIFreedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial NumNovember 17, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K252890ZenSeal ProJanuary 7, 2026
K222830Rainbow 360January 12, 2023
K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowAugust 31, 2022
K191548Nexus Universal Self-CureOctober 11, 2019
K182162OptiBond eXTRa UniversalNovember 7, 2018
K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsAugust 8, 2017
K163064Demi UltraJuly 18, 2017
K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate February 3, 2017
K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordJanuary 13, 2017
K162436EndoVac PureDecember 21, 2016
K162257P1145 Dental RestorativeNovember 7, 2016
K160441Identic and KromaFaze Alginate Dental Impression MaterialsJune 30, 2016
K123468DEMI ULTRAMarch 20, 2013
K123595NEXUS RMGIFebruary 19, 2013
K110747TEMPFLEXJune 14, 2011
K110092TAKE 1 ADVANCED RIGID TRAYApril 8, 2011
K102621SOLSTICEJanuary 28, 2011
K103351DMC COMPOSITE 2January 20, 2011
K101756TSCOctober 26, 2010
K102163REALSEAL XT SEALEROctober 16, 2010