ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314


Device Classification Name

implant, endosseous, root-form

510(k) Number K030243
Device Name ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
Original Applicant
IMTEC CORP.
2401 north commerce
ardmore, 
OK 
73401

Original Contact j.brad vance
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 01/23/2003
Decision Date 04/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No