CAM STRUCTSURE PRECISION MILLED BARS


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K080864
Device Name CAM STRUCTSURE PRECISION MILLED BARS
Applicant
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact tamara west
Correspondent
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact tamara west
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 03/28/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No