GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM


Device Classification Name

bracket, ceramic, orthodontic

510(k) Number K112707
Device Name GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
Applicant
ORTHO TECHNOLOGY, INC
17401 commerce park blvd.
tampa, 
FL 
33647

Applicant Contact jodi hutchins
Correspondent
ORTHO TECHNOLOGY, INC
17401 commerce park blvd.
tampa, 
FL 
33647

Correspodent Contact jodi hutchins
Regulation Number 872.5470
Classification Product Code
NJM  
Date Received 09/19/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No