GOLD CORE 35


Device Classification Name

alloy, gold-based noble metal

510(k) Number K023501
Device Name GOLD CORE 35
Original Applicant
PENTRON LABORATORY TECHNOLOGIES
53 north plains industrial rd.
wallingford, 
CT 
06492 -0724

Original Contact greg jimmie
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 10/18/2002
Decision Date 12/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No