AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE


Device Classification Name

handpiece, air-powered, dental

510(k) Number K072754
Device Name AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
Applicant
AXENIC DENTAL, INC.
259 east michigan ave.
suite 409
kalamazoo, 
MI 
49007

Applicant Contact joseph t sobota
Correspondent
AXENIC DENTAL, INC.
259 east michigan ave.
suite 409
kalamazoo, 
MI 
49007

Correspodent Contact joseph t sobota
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 09/27/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No