MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM


Device Classification Name

bracket, plastic, orthodontic

510(k) Number K050730
Device Name MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
Applicant
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Applicant Contact tammy lavery
Correspondent
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Correspodent Contact tammy lavery
Regulation Number 872.5470
Classification Product Code
DYW  
Subsequent Product Code
DYH  
Date Received 03/21/2005
Decision Date 03/31/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No