ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW


Device Classification Name

implant, endosseous, orthodontic

510(k) Number K081393
Device Name ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
Applicant
G & H WIRE CO.
11460 north meridian street
suite 150
carmel, 
IN 
46032

Applicant Contact carri graham
Correspondent
G & H WIRE CO.
11460 north meridian street
suite 150
carmel, 
IN 
46032

Correspodent Contact carri graham
Regulation Number 872.3640
Classification Product Code
OAT  
Date Received 05/19/2008
Decision Date 08/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No