HYPERELASTIC WIRE


Device Classification Name

wire, orthodontic

510(k) Number K112640
Device Name HYPERELASTIC WIRE
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 872.5410
Classification Product Code
DZC  
Date Received 09/12/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No