XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K024004
Device Name XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
Original Applicant
FRIADENT GMBH
21911 erie ln.
lake forest, 
CA 
92630

Original Contact carol patterson
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 12/04/2002
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No