SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS


Device Classification Name

scaler, ultrasonic

510(k) Number K080089
Device Name SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
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 872.4850
Classification Product Code
ELC  
Date Received 01/14/2008
Decision Date 09/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No