BIOMERS TRANSLUCENT ORTHODONTIC WIRE


Device Classification Name

bracket, plastic, orthodontic

510(k) Number K081143
Device Name BIOMERS TRANSLUCENT ORTHODONTIC WIRE
Applicant
BIOMERS PRODUCT, LLC
2316 pine ridge road
suite 459
naples, 
FL 
34109

Applicant Contact george aliphtiras
Regulation Number 872.5470
Classification Product Code
DYW  
Subsequent Product Code
DZC  
Date Received 04/22/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No