BIODENTA DENTAL IMPLANT SYSTEM – BONE LEVEL


Device Classification Name

implant, endosseous, root-form

510(k) Number K111003
Device Name BIODENTA DENTAL IMPLANT SYSTEM – BONE LEVEL
Applicant
BIODENTA SWISS AG
tramstrasse 16
berneck, st. gallen, 

CH

9442

Applicant Contact david eiler
Correspondent
BIODENTA SWISS AG
tramstrasse 16
berneck, st. gallen, 

CH

9442

Correspodent Contact david eiler
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 04/11/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No