DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE


Device Classification Name

system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

510(k) Number K122065
Device Name DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
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 872.3661
Classification Product Code
NOF  
Date Received 07/13/2012
Decision Date 02/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No