AXIS SYSTEM


Device Classification Name

handpiece, air-powered, dental

510(k) Number K072989
Device Name AXIS SYSTEM
Applicant
DENTSPLY INTL., INC.
susquehanna commerce center
221 w philadelphia st. ste 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTL., INC.
susquehanna commerce center
221 w philadelphia st. ste 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 10/23/2007
Decision Date 01/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No