SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS


Device Classification Name

implant, endosseous, orthodontic

510(k) Number K111809
Device Name SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
Applicant
BIOMATERIALS KOREA INC.
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
BIOMATERIALS KOREA INC.
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 872.3640
Classification Product Code
OAT  
Date Received 06/27/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No