T3 DENTAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K122300
Device Name T3 DENTAL IMPLANT
Applicant
BIOMET 3I
4555 riverside dr.
palm bch gdns, 
FL 
33410

Applicant Contact tamara west
Correspondent
BIOMET 3I
4555 riverside dr.
palm bch gdns, 
FL 
33410

Correspodent Contact tamara west
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 07/31/2012
Decision Date 01/30/2013
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