DAMON 4CLEAR


Device Classification Name

bracket, ceramic, orthodontic

510(k) Number K081415
Device Name DAMON 4CLEAR
Applicant
ORMCO CORP.
1717 west collins avenue
orange, 
CA 
92867

Applicant Contact wendy garman
Correspondent
ORMCO CORP.
1717 west collins avenue
orange, 
CA 
92867

Correspodent Contact wendy garman
Regulation Number 872.5470
Classification Product Code
NJM  
Date Received 05/20/2008
Decision Date 09/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No