Instrument, Diamond, Dental
Dental · 21 CFR 872.4535
Recent MDR events
36 adverse event reports on file
- PRIVA ROTARY INSTRUMENTS¿ DIAMOND BURSMay 15, 2026MalfunctionPremier Dental Products Company2511556-2026-00004
- SOLO DIAMONDFeb 18, 2025InjuryPremier Dental Products Company2511556-2025-00001
- DIAM.B.S.PREP.CONIC. FG M 010Dec 6, 2024MalfunctionMaillefer Instruments Holding Sarl8031010-2024-00158
- DIAM.B.S.PREP.CONIC. FG M 010Dec 6, 2024MalfunctionMaillefer Instruments Holding Sarl8031010-2024-00159
- DIAM.B.S.PREP.CONIC. FG M 010Dec 6, 2024MalfunctionMaillefer Instruments Holding Sarl8031010-2024-00157
- SOLO DIAMONDNov 14, 2024MalfunctionPremier Dental Products Company2511556-2024-00003
- SOLO DIAMONDNov 6, 2024InjuryPremier Dental Products Company2511556-2024-00002
- TELESCOPINT ROUND DIAMONDApr 23, 2024InjuryBrasseler Usa2025102-2024-00002
- SOLO DIAMONDFeb 29, 2024InjuryPremier Dental Products Company2511556-2024-00001
- SOLO DIAMONDJan 19, 2024InjuryPremier Dental Products Company2511556-2023-00008
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
115 firms currently registered for this product code
Kazan Medical Instruments Plant
Kazan Tatarstan, RU
Huizhou Videya Technology Co., Ltd.
Huizhou Guangdong, CN
Abrasive Technology, Llc
LEWIS CENTER, OH, US
Lares Research
CHICO, CA, US
Trirock Dental Llc
Lakewood, NJ, US
Imperial Trading Limited
Bridgetown Saint Michael, BB
Premium Plus Dental Supplies Inc
BROOKLYN, NY, US
Edenta Etablissement
SCHAANWALD Mauren, LI
Ss White Burs Llc
LAKEWOOD, NJ, US
Ortho Solutions Lc
Lake Saint Louis, MO, US
Maillefer Instruments Holding Sarl
BALLAIGUES Vaud, CH
Lasco Diamond Products, Inc.
CHATSWORTH, CA, US
Toyo Medical Co.
Doral, FL, US
Jota Ag
RUETHI, SG Sankt Gallen, CH
Bioline Dental Implant Systems Ltd
Migdal Tefen Northern, IL
Kerr Corporation
Pomona, CA, US
Eoca Md Pty Limited
Double Bay New South Wales, AU
Kerr Italia, S.r.l.
SCAFATI Salerno, IT
Pdt, Inc.
MSLA, MT, US
Sirona Dental Systems Gmbh
BENSHEIM Hesse, DE
Acurata Gmbh & Co. Kgaa
Thurmansbang Bavaria, DE
Coltene/whaledent Ag
ALTSTAETTEN Sankt Gallen, CH
Strauss & Co.
Raanana Central, IL
Dfs-diamon Gmbh
RIEDENBURG Bavaria, DE
Innopex Limited
Toronto Ontario, CA
510(k) clearances
21 clearances for this product code
- Beavers Dental, Div. Sybron Canada, Ltd.Apr 20, 2012
K120037 · BLUWHITE DIAMOND DENTAL BURS MODIFIED
- Sophos TechnologicSep 16, 1994
K943841 · SOPHOS DENTAL DIAMOND
- Dunhall Pharmaceuticals, Inc.Aug 29, 1994
K940908 · DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS
- Eare Consulting ServiceFeb 3, 1994
K934981 · DENTAL DRILL
- Alpha Industrializacao DE Metais Ltda.Mar 16, 1993
K923757 · DENTAL DIAMOND DRILLS
- The Lahr Consulting Group, Inc.Jan 14, 1992
K913651 · MANI DIA-BURS
- Micro-Aire Surgical Instruments, Inc.Jul 13, 1990
K901967 · DENDIA WERK BURS AND CUTTING DISCS
- Diamond Rotary and Carbide Intl.Jul 9, 1990
K901262 · F.G. LASER (DENTAL BUR)