SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS


Device Classification Name

handpiece, air-powered, dental

510(k) Number K073478
Device Name SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 w. collins ave.
orange, 
CA 
92867

Applicant Contact colleen boswell
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 w. collins ave.
orange, 
CA 
92867

Correspodent Contact colleen boswell
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 12/11/2007
Decision Date 09/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No