ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K110565
Device Name ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
Applicant
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact jose e cabrera
Correspondent
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact jose e cabrera
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 02/28/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No