MTA ROOT CANAL SEALER


Device Classification Name

resin, root canal filling

510(k) Number K080203
Device Name MTA ROOT CANAL SEALER
Applicant
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 01/28/2008
Decision Date 03/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No