SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K110484
Device Name SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
Applicant
NOVOCOL, INC.
416 south taylor ave.
louisville, 
CO 
80027

Applicant Contact cora bracho-troconis
Correspondent
NOVOCOL, INC.
416 south taylor ave.
louisville, 
CO 
80027

Correspodent Contact cora bracho-troconis
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 02/18/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No