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 K192042
Device Name Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH CH-6110
Applicant Contact Marco Steiner
Correspondent
TELOS Partners, LLC
571 Christina Lake Drive
Lakeland,  FL  33813
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Subsequent Product Code
NPM  
Date Received07/31/2019
Decision Date 08/29/2019
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
-
-