P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K080239
Device Name P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
Applicant
STRAUMANN MANUFACTURING, INC.
60 minuteman rd.
andover, 
MA 
01810

Applicant Contact elaine alan
Correspondent
STRAUMANN MANUFACTURING, INC.
60 minuteman rd.
andover, 
MA 
01810

Correspodent Contact elaine alan
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 01/31/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No