SAPPHIRE CERAMIC BRACKET


Device Classification Name

bracket, ceramic, orthodontic

510(k) Number K073045
Device Name SAPPHIRE CERAMIC BRACKET
Applicant
ORTHO TECHNOLOGY, INC
17401 commerce park blvd.
tampa, 
FL 
33647

Applicant Contact paul williams
Correspondent
ORTHO TECHNOLOGY, INC
17401 commerce park blvd.
tampa, 
FL 
33647

Correspodent Contact paul williams
Regulation Number 872.5470
Classification Product Code
NJM  
Date Received 10/29/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No