P.004 NC ANATOMIC ABUTMENTS

Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K071357
Device Name P.004 NC ANATOMIC ABUTMENTS
Applicant
INSTITUT STRAUMANN AG
60 minuteman road
andover, 
MA 
01810

Applicant Contact paige sweeney
Correspondent
INSTITUT STRAUMANN AG
60 minuteman road
andover, 
MA 
01810

Correspodent Contact paige sweeney
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 05/15/2007
Decision Date 09/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No