COMPONEER


Device Classification Name

material, tooth shade, resin

510(k) Number K112168
Device Name COMPONEER
Applicant
COLTENE/WHALEDENT AG
235 ascot parkway
cuyahoga falls, 
OH 
44223

Applicant Contact mark van meter
Correspondent
COLTENE/WHALEDENT AG
235 ascot parkway
cuyahoga falls, 
OH 
44223

Correspodent Contact mark van meter
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 07/28/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No