BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K072642
Device Name BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
Applicant
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

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

Correspodent Contact diana taylor
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 09/18/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls