CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE


Device Classification Name

handpiece, air-powered, dental

510(k) Number K080240
Device Name CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
Applicant
PROMIDENT LLC
242 north main st.
new city, 
NY 
10956

Applicant Contact gary kris
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 01/31/2008
Decision Date 02/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party Yes

Combination Product

No