Is this your brand? Sign in to claim ownership.
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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000114355
- DUNS Number
- —
Catalogue (950)
Page 15 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tatum Surgical Unipost System | Analog UCLA Retention Screw 2.5mm LH | FDA UDI | Class II | Active |
| Tatum Post Guide 40° | Post Guide 40° | FDA UDI | Class I | Active |
| Tatum Surgical/Abutment (Post) | Abutment/5.0 Blank straight post for Integrity 5.0 Implants | FDA UDI | Class II | Unknown |
| Torque Wrench 30Ncm Breakaway | Torque Wrench 30 Ncm | FDA UDI | Class I | Active |
| TatumSurgical/Abutment (Post) | Abutment/4.5mm x 60 degree Post | FDA UDI | Class II | Unknown |
| TatumSurgical/D Implant | D2S - Fin/4.5x5.5x16 | FDA UDI | Class II | Unknown |
| TatumSurgical/Abutment (Integrity Post) | Abutment/3.7mm x 0 degree Straight Integrity Post | FDA UDI | Class II | Unknown |
| TatumSurgical/3.7-4.5x5.0mm Integrity Platform Switch Healing Cuff | 3.7-4.5x5.0mm Integrity PS-HC | FDA UDI | Class II | Active |
| Brasseler | DR4.0x17TP | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge head implant | One Piece/5.0x20CB | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | Osteotome Tapered 6.0 x 21 Straight | FDA UDI | Class I | Active |
| Tatum Surgical/IP 5.0 x 8.0mm | IP 5.0 x 8.0mm | FDA UDI | Class II | Active |
| Tatum Surgical/Hand Tool | Hand Tool / HT.13 | FDA UDI | Class I | Active |
| Tatum Sinus Retractor | Tatum Sinus Retractor #5 | FDA UDI | Class I | Active |
| Tatum Surgical/One Piece Crown and Bridge head implant | One Piece/5.0x23CB | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | OsteotomeZ RT 4.0 | FDA UDI | Class I | Active |
| Tatum One Piece Implant Kit Master | Master One Piece Implant Kit 3.0-8.0 | FDA UDI | Class I | Active |
| TatumSurgical/4.0x3.0mm Integrity Implant Healing Cuff | 4.0x3.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| Mouth Gag (L) | Mouth Gag (L) | FDA UDI | Class I | Active |
| Tatum Surgical/Abutment (Post) | Abutment/4.5mm x 50 degree Post Short | FDA UDI | Class II | Unknown |
| Tatum Surgical/Hand Tool | Hand Tool / HT.11 | FDA UDI | Class I | Active |
| Tatum Surgical-Integrity Implant 8.0x14, Bone Level | ITI-B 8.0x14 | FDA UDI | Class II | Active |
| Brasseler | TTAP 7.0x17 | FDA UDI | Class I | Active |
| TatumSurgical/Tapered Implant | Tapered/6.0x20 | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece Crown and Bridge Angled head implant | One Piece/3.0x23 CBA | FDA UDI | Class II | Unknown |
| Tatum Surgical Bone Fixation Screw | Bone Fix Scw 1.75x8mm | FDA UDI | Class II | Active |
| Zoll Scalpel Handle Round | Scalpel Handle Round Z-4206 XL | FDA UDI | Class I | Active |
| Tatum Surgical-Analog | Analog 5.0mm | FDA UDI | Class I | Active |
| Tatum Surgical Bone Fixation Screw | Bone Fix Scw 1.5x4mm | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Integrity Post) | Abutment/4.5mm x 0 degree Straight Integrity Post | FDA UDI | Class II | Unknown |
| Tatum Surgical Mallet | Mallet T | FDA UDI | Class I | Active |
| Tatum Integrity Implant Kit Box | Tatum Integrity Implant Kit Box | FDA UDI | Class I | Active |
| TatumSurgical/Abutment (Post) | Abutment/4.5mm x 0 degree (Straight) Post - Short | FDA UDI | Class II | Active |
| Tatum Surgical/Integrity Implant | Integrity/3.7 x 9 | FDA UDI | Class II | Active |
| Tatum Sinus Retractor Kit Box | Tatum Sinus Retractor Kit Box | FDA UDI | Class I | Active |
| Tatum Surgical/Integrity Implant | Integrity/4.0 x 20 | FDA UDI | Class II | Active |
| TatumSurgical/6.0x1.0mm Integrity Implant Healing Cuff | 6.0x1.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| Tatum Surgical / Healing Cuff for 3.7mm Integrity Implant | Healing Cuff for 3.7mm Integrity Implant | FDA UDI | Class II | Active |
| TatumSurgical/Screw Implant | Screw/7.0 x 17 | FDA UDI | Class II | Active |
| TatumSurgical/Screw Implant | Screw/4.5 x 17 | FDA UDI | Class II | Active |
| Tatum Paralleling Pin | Paralleling Pin | FDA UDI | Class I | Active |
| TatumSurgical/6.0x5.0mm Integrity Implant Healing Cuff | 6.0x5.0mm Integrity Implant Healing Cuff | FDA UDI | Class II | Active |
| TatumSurgical/Abutment (Integrity Post) | Abutment 5.0mm x 0 degree (Straight) Integrity Post | FDA UDI | Class II | Active |
| Tatum Surgical/One Piece small ball head implant | One Piece/4.5x20SB | FDA UDI | Class II | Unknown |
| Tatum Surgical/Hand Tool | Hand Tool / HT.07L | FDA UDI | Class I | Active |
| ITL Dental | HTT .050 driver (Short) | FDA UDI | Class I | Active |
| TatumSurgical/Large Ball Post | Large Ball Post/4.5mmx5mm | FDA UDI | Class II | Unknown |
| Tatum Surgical-Osteotome | Osteotome Tapered 3.5 x 18 Offset | FDA UDI | Class I | Active |
| TatumSurgical/Tapered Implant | Tapered/5.0x20 | FDA UDI | Class II | Active |
| Scalpel Handle - Round | Scalpel Handle - Round | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.