TWINKY STAR


Device Classification Name

material, tooth shade, resin

510(k) Number K022797
Device Name TWINKY STAR
Original Applicant
VOCO GMBH
19379 blue lake loop
bend, 
OR 
97702

Original Contact gerald w shipps
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 08/23/2002
Decision Date 10/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No