FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS


Device Classification Name

implant, endosseous, root-form

510(k) Number K073075
Device Name FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
Applicant
DENTSPLY INTERNATIONAL, INC.
susquehanna commerce ctr., 221
w. philadelphia st., suite 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL, INC.
susquehanna commerce ctr., 221
w. philadelphia st., suite 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 10/31/2007
Decision Date 03/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No