Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K161762
Device Name DynaMatrix/Dynamatrix Plus
Applicant
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact Perry W. Guinn
Correspondent
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact Perry W. Guinn
Regulation Number872.3930
Classification Product Code
NPL  
Date Received06/27/2016
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-