KLS-MARTIN ORTHO ANCHORAGE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K033483
Device Name KLS-MARTIN ORTHO ANCHORAGE SYSTEM
Applicant
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Applicant Contact jennifer damato
Correspondent
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Correspodent Contact jennifer damato
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 11/04/2003
Decision Date 01/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No