BIODENTA CUSTOMIZED ABUTMENT


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K110778
Device Name BIODENTA CUSTOMIZED ABUTMENT
Applicant
BIODENTA SWISS AG
tramstrasse 16
berneck, 

CH

9442

Applicant Contact angela blackwell
Correspondent
BIODENTA SWISS AG
tramstrasse 16
berneck, 

CH

9442

Correspodent Contact angela blackwell
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 03/21/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No