QUANTEC-E IRRIGATION SYSTEM


Device Classification Name

unit, operative dental

510(k) Number K991035
Device Name QUANTEC-E IRRIGATION SYSTEM
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 west collins ave.
orange, 
CA 
92867

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

Correspodent Contact colleen boswell
Regulation Number 872.6640
Classification Product Code
EIA  
Date Received 03/29/1999
Decision Date 06/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No