ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES


Device Classification Name

handpiece, air-powered, dental

510(k) Number K072554
Device Name ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
Applicant
SABLE INDUSTRIES, INC.
581 whiles court
erie, 
CO 
80516

Applicant Contact kevin randall
Correspondent
SABLE INDUSTRIES, INC.
581 whiles court
erie, 
CO 
80516

Correspodent Contact kevin randall
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 09/10/2007
Decision Date 11/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No