CEREC OPTI SPRAY


Device Classification Name

material, impression

510(k) Number K080882
Device Name CEREC OPTI SPRAY
Applicant
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, 

DE

d-64625

Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 03/31/2008
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No