IONOFIL COLOR AC

Device Classification Name

cement, dental

510(k) Number K033068
Device Name IONOFIL COLOR AC
Applicant
VOCO GMBH
19379 blue lake loop
bend, 
OR 
97702

Applicant Contact gerald w shipps
Correspondent
VOCO GMBH
19379 blue lake loop
bend, 
OR 
97702

Correspodent Contact gerald w shipps
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 09/29/2003
Decision Date 10/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No