ORTHOSLENDERIZER


Device Classification Name

handpiece, air-powered, dental

510(k) Number K111249
Device Name ORTHOSLENDERIZER
Applicant
ORTHOMATICS, INC.
200 west county line road #340
highlands ranch, 
CO 
80129

Applicant Contact paul rocke
Correspondent
ORTHOMATICS, INC.
200 west county line road #340
highlands ranch, 
CO 
80129

Correspodent Contact paul rocke
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 05/03/2011
Decision Date 02/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No