ANKYLOS TEMPORARY ABUTMENT BALANCE


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K073073
Device Name ANKYLOS TEMPORARY ABUTMENT BALANCE
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 872.3630
Classification Product Code
NHA  
Date Received 10/31/2007
Decision Date 02/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No