SCULPTURE PLUS NANO-HYBRID COMPOSITE


Device Classification Name

material, tooth shade, resin

510(k) Number K023742
Device Name SCULPTURE PLUS NANO-HYBRID COMPOSITE
Original Applicant
PENTRON LABORATORY TECHNOLOGIES
53 north plains industrial rd.
wallingford, 
CT 
06492 -0724

Original Contact annmarie tenero
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 11/07/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No