ADMIRA PROTECT


Device Classification Name

sealant, pit and fissure, and conditioner

510(k) Number K021844
Device Name ADMIRA PROTECT
Original Applicant
VOCO GMBH
19379 blue lake loop
bend, 
OR 
97702

Original Contact gerald w shipps
Regulation Number 872.3765
Classification Product Code
EBC  
Date Received 06/05/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No