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 K101453
Device Name VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
Applicant
Obi Biologics, Inc.
4620 71st St., Bldg. 79
Lubbock,  TX  79424
Applicant Contact DUSTYN WEBB
Correspondent
Obi Biologics, Inc.
4620 71st St., Bldg. 79
Lubbock,  TX  79424
Correspondent Contact DUSTYN WEBB
Regulation Number872.3930
Classification Product Code
NPL  
Date Received05/25/2010
Decision Date 07/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-