FIBERFILL SGP


Device Classification Name

gutta-percha

510(k) Number K023819
Device Name FIBERFILL SGP
Original Applicant
PENTRON CLINICAL TECHNOLOGIES
53 north plains industrial rd.
wallingford, 
CT 
06492 -0724

Original Contact annmarie tenero
Regulation Number 872.3850
Classification Product Code
EKM  
Date Received 11/15/2002
Decision Date 03/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls