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Sign in to claim this brandSUNCOAST DENTAL, INC.
US
Last updated September 17, 2026
What SUNCOAST DENTAL, INC. makes
Suncoast Dental, Inc. manufactures dental implants and related surgical tools, including screw-type endosteal implants (both one-piece and two-piece designs), temporary and permanent preformed suprastructures, and reusable surgical instruments like fluted drill bits and osteotomes. Their product line also includes reusable depth/angle gauges for dental implantation procedures and various abutment posts for implant attachment.
The company’s devices are regulated under the FDA’s classification system, with products falling into Class I and Class II categories, and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for dental implants and surgical instruments.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Suncoast Dental, Inc. manufacture?
Suncoast Dental, Inc. specializes in dental implants and associated surgical tools. Their product line includes screw-type endosteal dental implants (both one-piece and two-piece designs), temporary and permanent preformed suprastructures for implants, reusable surgical instruments like fluted drill bits and osteotomes, and reusable depth/angle gauges for precise dental implantation. These devices are designed to support dental restoration procedures.
Where is Suncoast Dental, Inc. based, and does that affect its regulatory compliance?
Suncoast Dental, Inc. is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including classification under the agency’s system. The FDA’s Unique Device Identifier (UDI) database lists their products, ensuring traceability and regulatory transparency for dental implants and surgical instruments.
Which regulatory registries or databases list Suncoast Dental, Inc.’s devices?
Suncoast Dental, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring regulatory compliance and transparency for products like dental implants and surgical tools.
How are Suncoast Dental, Inc.’s devices classified under FDA regulations?
Suncoast Dental, Inc.’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 4500 140th Ave N Ste 112, CLEARWATER, FL, 33762
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1000114355
- DUNS Number
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Catalogue (950)
Page 19 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tatum Surgical IP Press Fit Angled Abutment | IP-PN-4.5 x 15° Abutment | FDA UDI | Class II | Unknown |
| Brasseler | DR1.8TW | FDA UDI | Class I | Active |
| Tatum Surgical-Integrity Implant 4.5x14mm, Bone Level | ITI-B 4.5x14 | FDA UDI | Class II | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.25 | FDA UDI | Class I | Active |
| TatumSurgical/Tapered Implant | Tapered/7.0x11 | FDA UDI | Class II | Active |
| Tatum Integrity Implant Kit | Master Integrity Implant Kit 3.7-8.0 | FDA UDI | Class I | Active |
| Tatum D2 Socket Formers | D2 Socket formers | FDA UDI | Class I | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.10 | FDA UDI | Class I | Active |
| Tatum Surgical-Screw Driver | Bone Fixation Screw Latch-Grip Driver | FDA UDI | Class I | Active |
| Brasseler | TTAP 8.0x14 | FDA UDI | Class I | Active |
| TatumSurgical/Ball Post for Integrity 3.7-4.5, 3.5 x 5.0mm Cuff Height | 3.5 x 5mm Integrity ball post | FDA UDI | Class II | Unknown |
| Tatum Surgical IP Press Fit Abutment | IP-PN-5.0 x 6 (CB) Abutment | FDA UDI | Class II | Active |
| Tatum Serrated Offset Surgical Curette 12S | Serrated Offset Surgical Curette 12S | FDA UDI | Class I | Active |
| Tatum Channel Former D1 4.0mm | D1 4.0mm Channel former | FDA UDI | Class I | Active |
| Tatum Surgical Bone Fixation Screw Kit | E-Z bone Fixation Screw Kit | FDA UDI | Class II | Active |
| TatumSurgical/Screw Implant | Screw/4.0 x 11 | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece small ball head implant | One Piece/4.0 x 11SB | FDA UDI | Class II | Active |
| DDP Depth Gauge | Depth Gauge | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | OsteotomeZ BB 10.0 | FDA UDI | Class I | Active |
| Tatum EZ-Driver Hex | EZ-Driver Hex | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog ITI Temp Abutment 5.0 | FDA UDI | Class II | Active |
| Tatum One-Piece Implant Kit Box | Tatum One-Piece Implant Kit Box | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset RB 3.5 | FDA UDI | Class I | Active |
| Tatum Surgical IP Press Fit Angled Abutment | IP-PN 5.0NS x 15° Abutment | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | OsteotomeZ RB 4.5 | FDA UDI | Class I | Active |
| Brasseler | DR4.5x14TP | FDA UDI | Class I | Active |
| Tatum Surgical/Abutment (Post) | Abutment/3.5 x 10 degree Push-In Post | FDA UDI | Class II | Active |
| Tatum Surgical/Abutment (Post) | Abutment/6.0mm x 50 degree Post Short | FDA UDI | Class II | Unknown |
| Tatum Surgical/Abutment (Post) | Abutment/4.0 x 0 degree Push-In Post | FDA UDI | Class II | Active |
| Tatum EZ Out Periotome | EZ Out Periotome #6 | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | Osteotome Tapered 4.5 x 12 Offset | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog ITI 6.0 | FDA UDI | Class I | Active |
| TatumSurgical/Abutment (Post) | Abutment/5.0mm x 20 degree Post - Short | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset RB 3.0 | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog (CB) 4.0-4.5 | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset RP 5.0 | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | Osteotome Tapered 4.5 x 15 Straight | FDA UDI | Class I | Active |
| Tatum Surgical-Integrity Implant 3.7x11, Bone Level | ITI-B 3.7x11 | FDA UDI | Class II | Active |
| Tatum Surgical/Platform Switch Post | PITI 5.0 (30°) Degree Platform Switch Post, 7mm tall for ITI 5.0 Implants | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset D1 4.0 | FDA UDI | Class I | Active |
| TatumSurgical/Abutment (Integrity Post) | Abutment/8.0mm x 30 degree Integrity Post | FDA UDI | Class II | Unknown |
| Tatum Surgical-Integrity Implant 3.7x09, Bone Level | ITI-B 3.7x09 | FDA UDI | Class II | Active |
| Brasseler | DR6.0x20TP | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge head implant | One Piece/4.5x14CB | FDA UDI | Class II | Active |
| Tatum Surgical-Integrity Implant 4.0x20mm, Bone Level | ITI-B 4.0x20 | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | OsteotomeZ RT 2.0 | FDA UDI | Class I | Active |
| O - Ring Large Black | O Ring Large Black | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog 6.0mm | FDA UDI | Class I | Active |
| R & S Series Fitting Tools | K811889 | FDA 510(k) | Class I | Active |
| R & S Series Implants | K811923 | FDA 510(k) | Class II | Active |
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