METAL OPAQUER


Device Classification Name

material, tooth shade, resin

510(k) Number K110859
Device Name METAL OPAQUER
Applicant
APEX DENTAL MATERIALS, INC.
330 telser road
lake zurich, 
IL 
60047

Applicant Contact chris kulton
Correspondent
APEX DENTAL MATERIALS, INC.
330 telser road
lake zurich, 
IL 
60047

Correspodent Contact chris kulton
Regulation Number 872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBD  
Date Received 03/28/2011
Decision Date 06/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No