Manufacturer registered with FDA
Suncoast Dental Corp.
Clearwater, FL, United States. Lists 13 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 13
- Brands and models
- 93
- 510(k) clearances
- 21981–1981
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Devices listed with FDA
What Suncoast Dental Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Suncoast Dental, Inc.Suncoast Dental, Inc. Dba Tatum Surgical | 2007 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Pilot Drill 1, 1.5, 1.8, 2Tapered Drill 3.5x11,14,17,20Tapered Drill 4.5x11,14,17,20Tapered Drill 4x11,14,17,20Tapered Drill 5x11,14,17,20Tapered Drill 6x11,14,17,20Tapered Drill 7x11,14,17Tapered Drill 8x11,14,17 | 2018 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Lister | Tatum Surgical | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Bending PliersBoley GaugeBone CaliperBone CarrierBone CutterBone Expander KitBone MolderEZ-Implant DriverEZ-Screw Fixation Driver HandleEZ-Universal Driver Short/Long 10 moreForceps Adson/Tissue/MicroNeedle HolderOrban KnifePost HolderRetractor TC / UofMRulerScalpel HandleScissors Gfox/Metz/Castroviejo Straight/CurvedSeldinTunneling Kit | 2023 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Housing for Small/Large Ball Posts | 2023 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Rongeur | 2018 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Depth Gauge | 2018 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Periosteal Elevators Single/KitPeriotome 1,2,3,4,5,6,7Sinus Curette 1,2,3,4,5,6,7,8,9,10 | 2018 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | BB Straight/Offset OsteotomeBS Straight/Offset OsteotomeChannel Former D1,2,3,4D1,2,3,4 Straight/Offset OsteotomeRB Straight/Offset OsteotomeRP Straight/Offset OsteotomeRT Straight/Offset Osteotome3 Diameter Straight/Offset Osteotome3.5 Diameter Straight/Offset Osteotome4 Diameter Straight/Offset Osteotome 5 more4.5 Diameter Straight/Offset Osteotome5 Diameter Straight/Offset Osteotome6 Diameter Straight/Offset Osteotome7 Diameter Offset Osteotome8 Diameter Offset Osteotome | 2018 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Lister | Tatum Surgical | 2018 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Positioner Set 1, 2Spacer Set 1, 2, 3, 4 | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | HT.10HT.11HT.12HT.13AHT.14HT.15HT.16HT.17HT.18HT.19 27 moreHT.20HT.21HT.22HT.23HT.26HT.27HT.29HT.30HT.31AHT.32AHt1HT2HT3HT3LHT4HT5HT6HT6LHT6UHT7HT7DHT7LHT7UHT8HT9HT9LRatchet | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Suncoast Dental Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Suncoast Dental, Inc. Dba Tatum Surgical (1), Impladent , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Jul 2022 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | DZE Root-Form Endosseous Implant |
| 18 Dec 2014 | K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Impladent , Ltd. | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUNCOAST DENTAL, INC.FDA reg. 1054986 | CLEARWATER, FL, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9003013). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.