PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K081291
Device Name PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
Applicant
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17405

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNTIONAL
221 w. philadelphia st. ste.60
susquehanna commerce crt. west
york, 
PA 
17405

Correspodent Contact helen lewis
Regulation Number 872.3750
Classification Product Code
DYH  
Subsequent Product Codes
EJF   NJM  
Date Received 05/07/2008
Decision Date 05/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No