Device Classification Name |
Barrier, Animal Source, Intraoral
|
510(k) Number |
K212463 |
Device Name |
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack |
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 Number | 872.3930
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/2021 |
Decision Date | 04/05/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|