The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Dynamatrix.
Device ID | K082058 |
510k Number | K082058 |
Device Name: | DYNAMATRIX |
Classification | Barrier, Animal Source, Intraoral |
Applicant | COOK BIOTECH, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | David J Collette |
Correspondent | David J Collette COOK BIOTECH, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Product Code | NPL |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-21 |
Decision Date | 2008-10-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00827002569034 | K082058 | 000 |
00827002512986 | K082058 | 000 |
00827002512993 | K082058 | 000 |
00827002568983 | K082058 | 000 |
00827002568990 | K082058 | 000 |
10827002512976 | K082058 | 000 |
10827002512983 | K082058 | 000 |
10827002512990 | K082058 | 000 |
10827002568980 | K082058 | 000 |
10827002568997 | K082058 | 000 |
10827002569000 | K082058 | 000 |
00827002513006 | K082058 | 000 |
00827002513013 | K082058 | 000 |
00827002513020 | K082058 | 000 |
00827002569010 | K082058 | 000 |
00827002569027 | K082058 | 000 |
00827002512979 | K082058 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DYNAMATRIX 77470114 3680916 Live/Registered |
Keystone Dental, Inc. 2008-05-09 |
![]() DYNAMATRIX 76171262 not registered Dead/Abandoned |
Dynamac Corporation 2000-11-27 |