DYNAMATRIX

Barrier, Animal Source, Intraoral

COOK BIOTECH, INC.

The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Dynamatrix.

Pre-market Notification Details

• 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

NIH GUDID Devices

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