SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE


Device Classification Name

bracket, plastic, orthodontic

510(k) Number K110796
Device Name SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
Applicant
BIOMERS PRODUCTS, LLC
1275 west 6th avenue
suite 399
vancouver, bc, 

CA

v6h 1a6

Applicant Contact daryl wisdahl
Regulation Number 872.5470
Classification Product Code
DYW  
Subsequent Product Code
DZC  
Date Received 03/22/2011
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No