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Premier Dental Products Co

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Known Names

premier dental products, premier dental products company

Recent Recalls

NumberClassProductDate
Z-1408-2025Class IIPremier Solo Diamond - Large Invented Cone; SKU: 807016C.February 27, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K260682Bond-PR™ Universal AdhesiveMarch 3, 2026
K253513MultiMatch Flow Chameleon AntiMicrobial CompositeNovember 7, 2025
K223632Premier's MultiMatch Universal Chameleon Restorative CompositeDecember 6, 2022
K141839PREMIER ETCHNovember 17, 2014
K132526KNIT-PAK+November 26, 2013
K131212PREMIER CERAMIC PRIMERAugust 26, 2013
K083695TRAXODENTApril 28, 2009
K062166ENAMEL PRONovember 21, 2006
K062683ENAMEL PRO VARNISHNovember 21, 2006
K061998PREMIER SELF-ETCHING BOND ENHANCEROctober 4, 2006
K061997PREMIER SELF-ETCHING ENAMEL SEALANTOctober 4, 2006
K051866PREMIER TEMPORARY CEMENTSeptember 6, 2005
K042215RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENTSeptember 21, 2004
K033309PREMIER IMPLANT CEMENT, MODEL 3001450January 26, 2004
K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408September 27, 2001
K010195PREMIER ULTRASONIC SCALER AND INSERTSApril 17, 2001
K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSJune 17, 1997
K941856PREMIER PROMAX BITE GUARDApril 5, 1995
K945395PREMIER MIRROR WARMERJanuary 18, 1995
K923332ELECTROSURGICAL ELECTRODESOctober 13, 1992