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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
- —
- FDA FEI Number
- 1000114355
- DUNS Number
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Catalogue (950)
Page 5 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Brasseler | DR5.0x11TP | FDA UDI | Class I | Active |
| Tatum Surgical/Ti-Base | PITI 5.0 Ti Base, 7mm tall for ITI 5.0 Implants | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | OsteoZ Offset D4 10.0 | FDA UDI | Class I | Active |
| Brasseler | TTAP 5.0x17 | FDA UDI | Class I | Active |
| Tatum Sinus Instrument Kit | Tatum Sinus Kit | FDA UDI | Class I | Active |
| Tatum EZ Out Periotome | EZ Out Periotome #7 | FDA UDI | Class I | Active |
| TatumSurgical/Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants | 2.5 RH Integrity Abutment Screw | FDA UDI | Class II | Active |
| TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0 x 5.0mm Cuff Height | 6.0 x 5mm Integrity ball post | FDA UDI | Class II | Unknown |
| Tatum Surgical-Integrity Implant 6.0x17mm, Bone Level | ITI-B 6.0x17 | FDA UDI | Class II | Active |
| Tatum Surgical-Integrity Implant 4.0x09, Bone Level | ITI-B 4.0x09 | FDA UDI | Class II | Active |
| Scalpel Remover | Scalpel Remover T/C | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog Burn Out Large BPAL | FDA UDI | Class I | Active |
| TatumSurgical/ITO HC 4.0 (CB)-Delrin HC for 4.0 One-Piece (CB) | Delrin Healing Cap for 4.0 One-Piece (CB) | FDA UDI | Class II | Unknown |
| TatumSurgical/Large Ball Post | Large Ball Post/4.0mmx1mm | FDA UDI | Class II | Unknown |
| TatumSurgical/Abutment (Post) | Abutment/3.5mm x 40 degree Post | FDA UDI | Class II | Unknown |
| Tatum Surgical-Analog | Analog ITI 6.0-8.0 XFer | FDA UDI | Class I | Active |
| Tatum D Implant Kit | D Implant Kit | FDA UDI | Class I | Active |
| TatumSurgical/Small Ball Post | Small Ball Post/3.5mmx3mm | FDA UDI | Class II | Unknown |
| Tatum Surgical-Integrity Implant 4.5x17mm, Bone Level | ITI-B 4.5x17 | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece Crown and Bridge Angled head implant | One Piece/3.0 x 17CBA | FDA UDI | Class II | Active |
| Tatum Surgical-Ball Post | Large Ball Post 4.5x3mm | FDA UDI | Class II | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.29 | FDA UDI | Class I | Active |
| Tatum Surgical/Integrity Implant | Integrity/7.0 x 14 | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece crown and bridge head implant | One Piece/3.5 x 11CB | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Post) | Abutment/6.0mm x 10 degree Post | FDA UDI | Class II | Active |
| TatumSurgical/8.0x1.0mm Integrity Implant Healing Cuff | 8.0x1.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| Brasseler | TTAP 5.0x11 | FDA UDI | Class I | Active |
| TatumSurgical/Abutment (Post) | Abutment/6.0mm x 0 degree (Straight) Post - Short | FDA UDI | Class II | Active |
| Tatum Surgical Bone Fixation Screw | Bone Fix Scw 1.75x12mm | FDA UDI | Class II | Active |
| ITL Dental | HTLT .050 driver (Long) | FDA UDI | Class I | Active |
| TatumSurgical/5.0x1.0mm Integrity Implant Healing Cuff | 5.0x1.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Integrity Post) | Abutment/3.7mm x 30 degree Integrity Post | FDA UDI | Class II | Unknown |
| TatumSurgical/HCS Integrity Cover Screw for 3.7- 4.5 Implants | 3.7-4.5 HCS Integrity Cover Screw | FDA UDI | Class II | Active |
| Scissors - Metzenbaum type | Scissors Metz. Straight | FDA UDI | Class I | Active |
| Tatum Surgical/Integrity Implant | Integrity/6.0 x 14 | FDA UDI | Class II | Active |
| Brasseler | TTAP 6.0x11 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge Angled head implant | One Piece/4.0 x 14CBA | FDA UDI | Class II | Active |
| Zoll Retractor, Uchy | Retractor, Uchy #1 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece crown and bridge head implant | One Piece/3.0 x 17CB | FDA UDI | Class II | Active |
| Tatum Surgical/IP 4.5 x 8.0mm | IP 4.5 x 8.0mm | FDA UDI | Class II | Active |
| TatumSurgical/Small Ball Post | Small Ball Post/3.5mmx1mm | FDA UDI | Class II | Unknown |
| Tatum Surgical-Integrity Platform Switching Abutment 6.0-8.0 | PITI-6.0-8.0 (0°) PS+1.5 | FDA UDI | Class II | Unknown |
| Forceps - Extraction | Forceps - Extraction | FDA UDI | Class I | Unknown |
| Brasseler | DR6.0x11TP | FDA UDI | Class I | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.12 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece crown and bridge head implant | One Piece/5.0 x 11CB | FDA UDI | Class II | Active |
| Tatum Sinus Instrument | Tatum Sinus #9 - Double ended | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog ITI UCLA 3.7-4.5 | FDA UDI | Class I | Active |
| Tatum Sinus Instrument | Tatum Sinus #5 - Double ended | FDA UDI | Class I | Active |
| Tatum Surgical/ITI 4.0 x 9mm | ITI 4.0 x 9mm | FDA UDI | Class II | Unknown |
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