ARTISTE SE FLOWABLE COMPOSITE, MODEL N280


Device Classification Name

material, tooth shade, resin

510(k) Number K072545
Device Name ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
Applicant
PENTRON CLINICAL TECHNOLOGIES
68-70 north plains industrial
road
wallingford, 
CT 
06492

Applicant Contact greg moreau
Correspondent
PENTRON CLINICAL TECHNOLOGIES
68-70 north plains industrial
road
wallingford, 
CT 
06492

Correspodent Contact greg moreau
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 09/10/2007
Decision Date 10/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls