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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 11 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tatum Surgical-Osteotome | OsteoZ Offset RB 4.5 | FDA UDI | Class I | Active |
| Brasseler | TTAP 6.0x14 | FDA UDI | Class I | Active |
| TatumSurgical/Large Ball Post | Large Ball Post/4.5mmx3mm | FDA UDI | Class II | Unknown |
| Tatum Surgical-Integrity Implant 7.0x14, Bone Level | ITI-B 7.0x14 | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset BS 5.0 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece crown and bridge head implant | One Piece/4.0 x 17CB | FDA UDI | Class II | Active |
| Tatum Sinus Retractor | Tatum Sinus Retractor #3 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece small ball head implant | One Piece/5.0 x 11SB | FDA UDI | Class II | Active |
| TatumSurgical/7.0x3.0mm Integrity Implant Healing Cuff | 7.0x3.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Integrity Post) | Abutment/5.0mm x 30 degree Integrity Post | FDA UDI | Class II | Unknown |
| TatumSurgical/Ball Post for Integrity 5.0, 5.0 x 3.0mm Cuff Height | 5.0 x 3mm Integrity ball post | FDA UDI | Class II | Active |
| TatumSurgical/Tapered Implant | Tapered/8.0x17 | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece Crown and Bridge head implant | One Piece/4.0 x 23CB | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | Osteotome Tapered 3.0 x 23 Offset | FDA UDI | Class I | Active |
| Tatum Surgical-Integrity Platform Switching Abutment 5.0, 30° | PITI-5.0 (30°) PS+1.5 | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | Osteotome Tapered 3.0 x 18 Offset | FDA UDI | Class I | Active |
| Brasseler | DR2.0TW | FDA UDI | Class I | Active |
| Periosteal Elevator | Periosteal | FDA UDI | Class I | Active |
| DDP Osseodensification Bur Kit | Osseodensification Bur Kit | FDA UDI | Class I | Unknown |
| Tatum Surgical-Integrity Implant 4.0x17mm, Bone Level | ITI-B 4.0x17 | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Post) | Abutment/4.5mm x 20 degree Post - Short | FDA UDI | Class II | Active |
| Implant Positioners | Implant positioners Set #2 | FDA UDI | Class I | Active |
| TatumSurgical/Screw Implant | Screw/6.0 x 14 | FDA UDI | Class II | Active |
| TatumSurgical/Screw Implant | Screw/6.0 x 17 | FDA UDI | Class II | Active |
| Tatum Surgical-Osteotome | Osteotome Tapered 4.5 x 15 Offset | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset RP 4.5 | FDA UDI | Class I | Active |
| Tatum Surgical IP Press Fit Abutment | IP-PN-5.0 x 4 (CB) Abutment | FDA UDI | Class II | Active |
| TatumSurgical/ITO HC 4.5 (CB)-Delrin HC for 4.5 One-Piece (CB) | Delrin Healing Cap for 4.5 One-Piece (CB) | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | OsteotomeZ RP 5.0 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge head implant | One Piece/4.0 x 20CB | FDA UDI | Class II | Unknown |
| Tatum Surgical-Analog | Analog (SB) 4.0x11 | FDA UDI | Class I | Unknown |
| Periosteal Set Tunnel | Periosteal Tunneling Kit | FDA UDI | Class I | Active |
| Tatum Surgical-Ball Post | Small Ball Post 3.5x5mm | FDA UDI | Class II | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.14 | FDA UDI | Class I | Active |
| Tatum Tapered Implant Kit Box | Tatum Tapered Implant Kit Box | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece small ball head implant | One Piece/8.0x11SB | FDA UDI | Class II | Unknown |
| Brasseler | DR3.5x17TP | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog ITI UCLA 6.0-8.0 | FDA UDI | Class I | Active |
| Tatum Surgical-Ball Post | Small Ball Post 3.5x3mm | FDA UDI | Class II | Active |
| Tatum Sinus Instrument | Tatum Sinus #10 - Double ended | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge Angled head implant | One Piece/4.0 x 17CBA | FDA UDI | Class II | Active |
| DDP Extraction Forceps | Forceps (150-A) | FDA UDI | Class I | Active |
| Tatum Surgical-Osteotome | OsteoZ Offset RB 4.0 | FDA UDI | Class I | Active |
| Tatum Surgical/ITI 4.5 x 9mm | ITI 4.5 x 9mm | FDA UDI | Class II | Unknown |
| Tatum Surgical / Healing Cuff for 8.0mm Integrity Implant | Healing Cuff for 8.0mm Integrity Implant | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece crown and bridge head implant | One Piece/4.0 x 11CB | FDA UDI | Class II | Active |
| Seldin retractor | Seldin | FDA UDI | Class I | Active |
| Orban Knife | Orban Knife | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog 4.0mm UCLA | FDA UDI | Class I | Active |
| TatumSurgical/HCS Integrity Cover Screw for 6.0-8.0 Implants | 6.0-8.0 HCS Integrity Cover Screw | FDA UDI | Class II | Active |
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