PREMISE

Device Classification Name

material, tooth shade, resin

510(k) Number K032921
Device Name PREMISE
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 872.3690
Classification Product Code
EBF  
Date Received 09/22/2003
Decision Date 11/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No