COMPOSITE ALIGNER BUTTON


Device Classification Name

aligner, sequential

510(k) Number K080246
Device Name COMPOSITE ALIGNER BUTTON
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 872.5470
Classification Product Code
NXC  
Date Received 01/31/2008
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No