3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615


Device Classification Name

implant, endosseous, root-form

510(k) Number K033430
Device Name 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
Applicant
IMPLANT INNOVATIONS, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact tamara nelson
Correspondent
IMPLANT INNOVATIONS, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact tamara nelson
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 10/28/2003
Decision Date 11/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No