FIBER DISK AND BLOCK


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K112186
Device Name FIBER DISK AND BLOCK
Applicant
BIOLOREN SRL
via alessandro volta 59
saronno, 

IT

Applicant Contact andrea ratti
Correspondent
BIOLOREN SRL
via alessandro volta 59
saronno, 

IT

Correspodent Contact andrea ratti
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 07/29/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No