ACROSEAL ROOT CANAL OR APICAL SEALER


Device Classification Name

resin, root canal filling

510(k) Number K023976
Device Name ACROSEAL ROOT CANAL OR APICAL SEALER
Original Applicant
SEPTODONT S.A.S.
1050 connecticut ave nw
washington, 
DC 
20036

Original Contact wayne h matelski
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 11/27/2002
Decision Date 01/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No