GOLD CORE PLUS


Device Classification Name

alloy, metal, base

510(k) Number K023499
Device Name GOLD CORE PLUS
Original Applicant
PENTRON LABORATORY TECHNOLOGIES
53 north plains industrial rd.
wallingford, 
CT 
06492 -0724

Original Contact annmarie tenero
Regulation Number 872.3710
Classification Product Code
EJH  
Date Received 10/18/2002
Decision Date 01/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No