Agent, Polishing, Abrasive, Oral Cavity
Dental · 21 CFR 872.6030
Recent MDR events
102 adverse event reports on file
- FINISHING 30-DISC RA REF-EXPJul 28, 2026MalfunctionDentsply Llc2515379-2026-00163
- FINISHING 30-DISC RA REF-EXPJul 27, 2026MalfunctionDentsply Llc2515379-2026-00158
- FINISHING CUP RA REFILLJul 17, 2026MalfunctionDentsply Llc2515379-2026-00144
- FINISHING CUP RA REFILLJul 16, 2026MalfunctionDentsply Llc2515379-2026-00141
- FINISHING POINT RA REFILLJun 18, 2026MalfunctionDentsply Llc2515379-2026-00106
- FINISHING POINT RA REFILLJun 18, 2026MalfunctionDentsply Llc2515379-2026-00107
- FINISHING DISC RA REFILLJun 15, 2026InjuryDentsply Llc2515379-2026-00095
- FINISHING DISC RA REFILLJun 15, 2026MalfunctionDentsply Llc2515379-2026-00096
- FINISHING POINT RA REFILLJun 15, 2026MalfunctionDentsply Llc2515379-2026-00098
- FINISHING DISC RA REFILLJun 4, 2026MalfunctionDentsply Llc2515379-2026-00084
Event type breakdown
Registered firms
177 firms currently registered for this product code
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Gc America Inc.
ALSIP, IL, US
Liaoning Upcera Co.,ltd
Benxi Liaoning, CN
Oketz Logistics Llc
Coral Gables, FL, US
Henan Baistra Medical Devices Limited
Zhengzhou Henan, CN
Hu-friedy Mfg Co., Llc
Des Plaines, IL, US
Medivance Instruments Ltd.
HARLESDEN, LONDON London, City of, GB
Dylan Lucas International Inc
Vaughan Ontario, CA
Young Dental Manufacturing Co 1, Llc.
EARTH CITY, MO, US
Conamco Sa De Cv Medental Inc
C.P. 06880 Ciudad de Mexico, MX
Mti Precision Products
Coatesville, PA, US
Ortho Organizers, Inc.
Savannah, GA, US
Cargus Int'l, Inc.
CONGERS, NY, US
Viarden Lab Llc
Mission, TX, US
Kerr Italia, S.r.l.
SCAFATI Salerno, IT
Whip-mix Corp.
LOUISVILLE, KY, US
D.s.p. Industrial Eireli Epp
Campo Largo Parana, BR
Shenzhen Denco Medical Co., Ltd.
Shenzhen Guangdong, CN
Nakanishi Inc.
Kanuma Tochigi, JP
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Integra Lifesciences Corporation
Princeton, NJ, US
E. C. Moore Company, Inc.
Dearborn, MI, US
Dentsply Llc
MILFORD, DE, US
Bioclear Matrix Systems, Llc
Tacoma, WA, US
510(k) clearances
77 clearances for this product code
- E.M.S Electro Medical Systems S.ASep 11, 2017
K171189 · AIR-FLOW PLUS Prophylaxis powder
- Whip-Mix Corp.Mar 26, 2014
K131760 · WHIP MIX PREPPIES PLUS
- Dentsply International, Inc.Aug 6, 2012
K121698 · NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
- Osspray, Ltd.Mar 14, 2011
K103114 · OSSPRAY SYLC CR
- Sunstar Americas, Inc.Feb 3, 2011
K102053 · BUTLER CALCI-FLOR PROPHYLAXIS PASTE
- Voco GmbHOct 21, 2010
K101104 · REMIN PRO
- Preventive Technologies, Inc.Jun 17, 2010
K100539 · PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
- GC America, Inc.Apr 12, 2007
K070854 · GC MI PASTE PLUS