Cosmedent, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
28
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0211-2024Class IICosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide PolJuly 20, 2023
Z-0741-2018Class IICosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. UsSeptember 28, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K240714Insure® Universal; Insure® Universal AutomixJuly 24, 2024
K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridOctober 11, 2022
K211259Renamel BulkfillJune 24, 2021
K172707Renamel MicrofillDecember 5, 2017
K163480Renamel NANO +plusFebruary 24, 2017
K092730COSMEDENT BRUSHABLE COMPOSITENovember 20, 2009
K070583NANO COMPOSITEApril 16, 2007
K060881TEMPORARY CROWN & BRIDGE RESINMay 16, 2006
K052263MULTIPLE (TOOTH DESENSITIZER)December 16, 2005
K052501MULTIPLE RESIN TOOTH BONDING AGENTOctober 21, 2005
K042823COSMEDENT PIT & FISSURE SEALANTDecember 1, 2004
K041229MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)June 17, 2004
K040994COSMEDENT CORE PASTEJune 3, 2004
K030832PRIMOSPLINT SYSTEMSeptember 17, 2003
K011239GINDA GUARDFebruary 14, 2002
K993658RENAMEL SCULPTJanuary 18, 2000
K993659RENAMEL PACKJanuary 18, 2000
K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALNovember 9, 1998
K980799HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALOctober 28, 1998
K980298FLOWABLE HYBRIDMarch 9, 1998