SEAL & PROTECT PROTECTIVE SEALANT


Device Classification Name

varnish, cavity

510(k) Number K021805
Device Name SEAL & PROTECT PROTECTIVE SEALANT
Original Applicant
DENTSPLY INTL.
570 west college ave.
york, 
PA 
17405 -0872

Original Contact p. jeffery lehn
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 06/03/2002
Decision Date 08/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No