DURAFINISH ALL-CURE, MODEL S296


Device Classification Name

coating, filling material, resin

510(k) Number K080549
Device Name DURAFINISH ALL-CURE, MODEL S296
Applicant
PARKELL, INC.
300 executive dr.
edgewood, 
NY 
11717

Applicant Contact daniel r schechter, esq
Correspondent
PARKELL, INC.
300 executive dr.
edgewood, 
NY 
11717

Correspodent Contact daniel r schechter, esq
Regulation Number 872.3310
Classification Product Code
EBD  
Date Received 02/27/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No