Tester, Pulp
Dental · 21 CFR 872.1720
Recent MDR events
9 adverse event reports on file
- ENDO-ICEDec 20, 2024InjuryColtene Whaledent Inc.2416455-2024-00006
- ICE COOLING SPRAYOct 11, 2024InjuryUnkMW5161044
- HYGENIC ENDO-ICE REFRIGERANT SPRAYJul 8, 2021Injury2416455-2021-00002
- VITALITY SCANNER 2006Aug 6, 2014MalfunctionSybronendo2016150-2014-00435
- TOUCH N' HEATAug 26, 2013MalfunctionSybronendo2016150-2013-00101
- TOUCH N' HEATAug 26, 2013MalfunctionSybronendo2016150-2013-00100
- SYSTEM B HEAT SOURCEAug 15, 2013MalfunctionSybronendo2016150-2013-00075
- SYSTEM B HEAT SOURCEJul 12, 2013MalfunctionSybronendo2016150-2013-00071
- VITALITY SCANNER 2006Feb 4, 2013MalfunctionSybronendo2016150-2013-00001
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
29 firms currently registered for this product code
Kerr Corporation
Pomona, CA, US
Parkell, Inc.
EDGEWOOD, NY, US
Stoner Incorporated
Quarryville, PA, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Oketz Logistics Llc
Coral Gables, FL, US
Kerr Corporation
ORANGE, CA, US
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Denjoy Dental Co., Ltd
Changsha city Hunan, CN
3d Dental Desings And Development
Shaker Heights, OH, US
Coltene/whaledent Inc.
CUYAHOGA FALLS, OH, US
Cargus Int'l, Inc.
CONGERS, NY, US
Ecotec Manufacturing
Okeechobee, FL, US
Mainline Medical Dental Supply
North York Ontario, CA
Sanicure Bv
SCHIPHOL Noord-Holland, NL
B&l Biotech Co., Inc
Ansan City Gyeonggi, KR
Premium Plus Dental Supplies Inc
BROOKLYN, NY, US
Pac-dent Inc.
Brea, CA, US
Ortho Solutions Lc
Lake Saint Louis, MO, US
Mn Health, Inc
Chantilly, VA, US
Samtrade Supplies Inc.
TORONTO Ontario, CA
510(k) clearances
22 clearances for this product code
- Parkell, Inc.Sep 6, 2002
K022097 · THERMIQUE
- Sybron Endo/AnalyticJun 19, 2002
K021298 · ELEMENTS DIAGNOSTIC UNIT
- Specialites SeptodontOct 9, 2001
K012427 · PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
- Heatshield, Inc.Aug 6, 2001
K011666 · CHILLIT
- Sybron Dental Specialties, Inc.Feb 25, 1999
K990225 · ENDO ANALYZER, MODEL 8005, MODIFIED
- Sybron Dental Specialties, Inc.Dec 8, 1997
K973439 · ENDO ANALYZER, MODEL 8005
- Sybron Dental Specialties, Inc.Apr 7, 1997
K970715 · SYSTEM B HEAT SOURCE
- Sybron Dental Specialties, Inc.Dec 2, 1996
K963862 · TOUCH N' HEAT