FDA 510(k) Applications for Medical Device Product Code "EIE"
(Dam, Rubber)

FDA 510(k) Number Applicant Device Name Decision Date
K050318 BIOENVELOP AGRO, INC. BARI-KAD PACKING DEVICE 03/04/2005
K010935 BRITESMILE, INC. BRITESMILE BARRIER MATERIAL 09/05/2001
K040797 BRITESMILE, INC. BRITESMILE MASKING CREAM 04/02/2004
K151945 DENALI CORPORATION Triumph Resin Dam 02/18/2016
K043301 GC AMERICA, INC. GC TION GINGIVAL PROTECTOR 01/25/2005
K972775 INTERDENT, INC. FASTDAM 02/27/1998
K983227 KREATIV, INC. POWER BLOCK 12/11/1998
K182118 Mavrik Dental Systems Ltd armor LC 05/03/2019
K021524 PRIME DENTAL MANUFACTURING, INC. LIGHT CURE DENTAL DAM 07/19/2002
K022522 PULPDENT CORPORATION PULPDENT PUTTY DAM 09/26/2002
K021613 SHOFU DENTAL CORP. NIVEOUS LIQUID DAM 06/20/2002
K954990 THE HYGENIC CORP. DENTAL DAM 01/26/1996
K961472 WORLDWIDE DENTAL, INC. DENTAL DAM SILICONE 08/07/1996


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