ENDO-EZE MOTOR AND HANDPIECE


Device Classification Name

handpiece, air-powered, dental

510(k) Number K992380
Device Name ENDO-EZE MOTOR AND HANDPIECE
Applicant
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Applicant Contact scott e moore
Correspondent
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Correspodent Contact scott e moore
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 07/16/1999
Decision Date 10/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No