Dam, Rubber
Dental · 21 CFR 872.6300
Recent MDR events
31 adverse event reports on file
- FLEXI-DAMSep 19, 2024InjuryDent4you Ag.2416455-2024-00004
- HYGENICMar 8, 2022InjuryColtene/whaledent Inc.2416455-2022-00005
- HYGENIC DENTAL DAM THIN GREENAug 27, 2021Injury2416455-2021-00004
- HYGENIC DENTAL DAM THIN GREENAug 27, 2021Injury2416455-2021-00005
- HYGENIC FLEXI DAM NON-LATEX PURPLEDec 26, 2019InjuryColtene Whaledent Inc.2416455-2019-00004
- HYGENICJun 25, 2019InjuryColtene Whaledent Inc.2416455-2019-00002
- HYGENICOct 23, 2018MalfunctionColtene Whaledent Inc.2416455-2018-00013
- HYGENICSep 13, 2018MalfunctionColtene Whaledent Inc.2416455-2018-09131
- HYGENICAug 23, 2018MalfunctionColtene Whaledent Inc.2416455-2018-08233
- HYGENICAug 23, 2018MalfunctionColtene Whaledent Inc.2416455-2018-08237
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
120 firms currently registered for this product code
Pomee Corporation
Sialkot Punjab, PK
Oketz Logistics Llc
Coral Gables, FL, US
Tf New Material Sci And Tec Co.,ltd
Huainan Anhui, CN
Mainline Medical Dental Supply
North York Ontario, CA
Abracadabra Implants Ltd.
Or Yehuda Central, IL
Four D Rubber Co Ltd
HEANOR Derbyshire, GB
Ivoclar Vivadent Gmbh
Ellwangen Baden-Wurttemberg, DE
Prime Dental Manufacturing, Inc.
CHICAGO, IL, US
Coltene/whaledent Inc.
CUYAHOGA FALLS, OH, US
Fuzhou Delphin Bio-tech Co., Ltd.
Fuzhou Fujian, CN
Dentscare Ltda
Joinville Santa Catarina, BR
Sdi Ltd.
BAYSWATER Victoria, AU
Inter-med, Inc.
Racine, WI, US
Pulpdent Corporation
Watertown, MA, US
Wsd Labs Usa Inc
Tonawanda, NY, US
Maxill, Inc.
ST. THOMAS Ontario, CA
Huanghua Promisee Dental Co., Ltd
Huanghua Hebei, CN
Aseptico, Inc.
WOODINVILLE, WA, US
Smart Denture Conversions, Llc
Apex, NC, US
Dsi Dental Solutions Ltd
Ashdod Southern, IL
Towne Brothers (pvt.), Ltd.
SIALKOT Punjab, PK
Viarden Lab Llc
Mission, TX, US
Ivoclar Vivadent Ag
SCHAAN, LI
Jmu Dental, Inc
Fullerton, CA, US
510(k) clearances
33 clearances for this product code
- Mavrik Dental Systems, Ltd.May 3, 2019
K182118 · armor LC
- Denali CorporationFeb 18, 2016
K151945 · Triumph Resin Dam
- Bioenvelop Agro, Inc.Mar 4, 2005
K050318 · BARI-KAD PACKING DEVICE
- GC America, Inc.Jan 25, 2005
K043301 · GC TION GINGIVAL PROTECTOR
- Britesmile, Inc.Apr 2, 2004
K040797 · BRITESMILE MASKING CREAM
- Pulpdent CorporationSep 26, 2002
K022522 · PULPDENT PUTTY DAM
- Prime Dental Manufacturing, Inc.Jul 19, 2002
K021524 · LIGHT CURE DENTAL DAM
- Shofu Dental Corp.Jun 20, 2002
K021613 · NIVEOUS LIQUID DAM