XENO III DENTAL ADHESIVE


Device Classification Name

agent, tooth bonding, resin

510(k) Number K023776
Device Name XENO III DENTAL ADHESIVE
Original Applicant
DENTSPLY INTL.
570 west college ave.
york, 
PA 
17405 -0872

Original Contact p. jeffery lehn
Regulation Number 872.3200
Classification Product Code
KLE  
Date Received 11/12/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No