Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K173374 |
Device Name |
TSV BellaTek Encode Healing Abutments |
Applicant |
Biomet 3i |
4555 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Applicant Contact |
Nichole O’Neil |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Linda K. Schulz |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/27/2017 |
Decision Date | 12/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|