NEW OUTLINE


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K023079
Device Name NEW OUTLINE
Original Applicant
ANAXDENT GMBH
1730 pennsylvania n.w.
washington, 
DC 
20006

Original Contact dvorah richman
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 09/16/2002
Decision Date 10/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No