The following data is part of a premarket notification filed by Suncoast Dental, Inc. Dba Tatum Surgical with the FDA for Tatum Surgical Dental Implant System.
| Device ID | K213576 |
| 510k Number | K213576 |
| Device Name: | Tatum Surgical Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Suncoast Dental, Inc. Dba Tatum Surgical 4500 140th Avenue North Suite 112 Clearwater, FL 33762 |
| Contact | Tony Fiorello |
| Correspondent | Melissa Burbage PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-10 |
| Decision Date | 2022-07-15 |