Disk, Abrasive
Dental · 21 CFR 872.6010
Recent MDR events
6 adverse event reports on file
- JIFFY POLISHER COARSE, DISKMar 22, 2023InjuryUnknown1718912-2023-00002
- VENUS SUPRANov 12, 2013MalfunctionHeraeus Kulzer Gmbh1925223-2013-00158
- VENUS SUPRASep 17, 2013MalfunctionHeraeus Kulzer Gmbh3005665377-2013-00001
- VENUS SUPRASep 17, 2013MalfunctionHeraeus Kulzer Gmbh1925223-2013-00136
- CERAGLAZE PORCELAIN POLISHER (PRE-POLISH)Oct 15, 2008InjuryAxis Dental Corp.1645240-2008-11002
- POGO ONE STEP DIAMOND MICRO POLISHERApr 8, 2004InjuryDentsply Caulk2515379-2004-00182
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Ultradent Products, Inc.Open, ClassifiedMar 27, 2026
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Z-1689-2026 · View FDA record ↗ - Ivoclar Vivadent, Inc.TerminatedUnknown
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: R
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Z-2373-2016 · View FDA record ↗
Registered firms
92 firms currently registered for this product code
Garrison Dental Solutions
Spring Lake, MI, US
Shanghai Dochem Industries Co., Ltd.
SHANGHAI, CN
Integra Lifesciences Corporation
Princeton, NJ, US
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Parkell, Inc.
EDGEWOOD, NY, US
Young Innovations Inc.
Algonquin, IL, US
3r Industria E Comercio Ltda
SAO PAULO, BR
Vericom Co., Ltd.
Chuncheon-Si Gangwon, KR
Solventum Us Llc
Irvine, CA, US
Everbrands, Inc.
Garden Grove, CA, US
Jordco, Inc.
Hillsboro, OR, US
Onvet Medical Canada Inc
TORONTO Ontario, CA
Jota Ag
RUETHI, SG Sankt Gallen, CH
Gebr. Brasseler Gmbh & Co. Kg
LEMGO North Rhine-Westphalia, DE
E. C. Moore Company, Inc.
Dearborn, MI, US
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Hopf, Ringleb & Co. Gmbh & Cie.
BERLIN, DE
Mhm Grupo Diamante, S.a. De C.v.
MEXICO, MX
Samtrade Supplies Inc.
TORONTO Ontario, CA
Prismatik Dentalcraft, Inc.
Irvine, CA, US
Kash Sales Inc.
Richmond Hill Ontario, CA
Cosmedent, Inc.
CHICAGO, IL, US
International Orthodontic Services, Pc
Stafford, TX, US
Mdt Micro Diamond Technologies Ltd
AFULA Northern, IL
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
510(k) clearances
4 clearances for this product code