Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K151599 |
Device Name |
iSy Implant System |
Applicant |
Altatec GmbH |
Maybachstrasse 5 |
Wimsheim,
DE
D-71299
|
|
Applicant Contact |
Colleen Boswell |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Linda Schulz |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/12/2015 |
Decision Date | 10/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|