OSSEOTITE 2 DENTAL IMPLANTS


Device Classification Name

implant, endosseous, root-form

510(k) Number K111216
Device Name OSSEOTITE 2 DENTAL IMPLANTS
Applicant
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact martha i garay
Correspondent
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact martha i garay
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 05/02/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No