Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K213576 |
Device Name |
Tatum Surgical Dental Implant System |
Applicant |
Suncoast Dental, Inc. dba Tatum Surgical |
4500 140th Avenue North Suite 112 |
Clearwater,
FL
33762
|
|
Applicant Contact |
Tony Fiorello |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/10/2021 |
Decision Date | 07/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|