Gauge, Depth, Instrument, Dental
Dental · 21 CFR 872.4565
Recent MDR events
10 adverse event reports on file
- DEPTH GAGE 2.0/2.4 45MM LONGMar 18, 2024MalfunctionBiomet Microfixation0001032347-2024-00095
- DEPTH GAGE 2.0/2.4 45MM LONGFeb 14, 2022MalfunctionBiomet Microfixation0001032347-2022-00048
- GO DIRECT COLLARAug 28, 2020MalfunctionImplant Direct Sybron Manufacturing Llc3001617766-2020-06245
- GO DIRECT COLLARAug 28, 2020MalfunctionImplant Direct Sybron Manufacturing Llc3001617766-2020-06246
- GO DIRECT COLLARAug 28, 2020MalfunctionImplant Direct Sybron Manufacturing Llc3001617766-2020-06247
- GO DIRECT COLLARAug 28, 2020MalfunctionImplant Direct Sybron Manufacturing Llc3001617766-2020-06244
- 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGEJan 10, 2019MalfunctionBiomet Microfixation0001032347-2019-00021
- DEPTH GAGE 2.0/2.4 45MM LONGJul 26, 2017InjuryBiomet Microfixation0001032347-2017-00594
- DEPTH GAUGENov 17, 2016MalfunctionBiomet Microfixation0001032347-2016-00679
- DEPTH GAUGEFeb 16, 2012MalfunctionIntegra Lifesciences Corporation Oh/usa3004608878-2012-00030
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
141 firms currently registered for this product code
Preat Corporation
Santa Maria, CA, US
Huanghua Promisee Dental Co., Ltd
Huanghua Hebei, CN
Integra Lifesciences Corporation
Princeton, NJ, US
Mainline Medical Dental Supply
North York Ontario, CA
Dentium Co., Ltd.
Suwon-si Gyeonggi, KR
Ambler Surgical, Llc
EXTON, PA, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Hu-friedy Mfg. Co. Llc
Northbrook, IL, US
Osung Mnd Co., Ltd.
Gimpo-si Gyeonggi, KR
Confident Instruments
Sialkot Punjab, PK
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Otto Leibinger Gmbh
MUEHLHEIM Baden-Wurttemberg, DE
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Integra Lifesciences Production Corporation
Mansfield, MA, US
Win Wings Corp.
SIALKOT Punjab, PK
Kerr Corporation
ORANGE, CA, US
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Pac-dent Inc.
Brea, CA, US
Shenzhen Rogin Medical Co., Ltd
shenzhen Guangdong, CN
Julius Wirth Llc
Emmingen-Liptingen Baden-Wurttemberg, DE
Hdi Inc.
Seongnam-si Gyeonggi, KR
Complexus Medical
Mishawaka, IN, US
Precision Beauty & Dental Instruments Llc
Houston, TX, US
Schobell Industrial Ltda
Rio Claro Sao Paulo, BR
Keystone Dental Inc.
Irvine, CA, US
510(k) clearances
8 clearances for this product code
- Abiomed, Inc.Jul 9, 1991
K911643 · ABIODENT PERIOTEMP(R) SYSTEM
- Florida Probe Corp.Mar 13, 1989
K890493 · FLORIDA PROBE PERIODONTAL PROBE
- Abiomed, Inc.Feb 13, 1989
K885075 · ABIOMED PERIOTEMP(TM) PROBE
- Vine Valley ResearchJan 5, 1989
K884813 · MODEL 200A ELECTRONIC FORCE-SENSING PROBE
- Dentsply Intl.Apr 27, 1988
K880209 · PERIODONTAL PROBE - AUTOPROBE
- Bowen & Company, Inc.Jul 31, 1987
K872098 · CREMEEN ALVEOLAR BONE CALIPER
- Dr. Bernard LoewenthalJul 10, 1987
K872215 · PERIO-TEST
- National Patent Development Corp.Oct 22, 1982
K822793 · PIO ROOT CANAL INDICATOR