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SUNCOAST 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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LinkedIn
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Facebook
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Email
—
Phone
—
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 7 of 19
DeviceModel / ReferenceRegistriesClassStatus
TatumSurgical/Screw Implant Screw/3.5 x 20
FDA UDI
Class IIActive
Tatum Surgical/Integrity Implant Integrity/6.0 x 11
FDA UDI
Class IIActive
Scissors - Castroviejo Scissors - Castroviejo
FDA UDI
Class IActive
TatumSurgical/Abutment (Integrity Post) Abutment/6.0mm x 0 degree Straight Integrity Post
FDA UDI
Class IIUnknown
Tatum Surgical-Ball Post Large Ball Post 4.5x5mm
FDA UDI
Class IIActive
Tatum Surgical-Osteotome OsteoZ Offset RB 5.0
FDA UDI
Class IActive
Tatum Surgical/One Piece crown and bridge head implant One Piece/6.0 x 11CB
FDA UDI
Class IIActive
Tatum EZ Out Periotome EZ Out Periotome #1
FDA UDI
Class IActive
Tatum Surgical/Integrity Implant Integrity/5.0 x 14
FDA UDI
Class IIActive
Tatum Surgical/One Piece Crown and Bridge Angled head implant One Piece/3.5 x 20 CBA
FDA UDI
Class IIUnknown
TatumSurgical/HC ITI 3.7mm Integrity-Delrin HC for Integrity 3.7mm Implant Delrin Healing Cap for Integrity 3.7mm Implant
FDA UDI
Class IIUnknown
Tatum Surgical-Osteotome Osteotome Tapered 3.5 x 15 Offset
FDA UDI
Class IActive
Tatum Surgical-Tapered Osteotome Kit Tatum Tapered Straight Osteotome Kit
FDA UDI
Class IActive
TatumSurgical/D Implant D2S - Fin/4.5x4.5x16
FDA UDI
Class IIUnknown
Tatum EZ Out Periotome EZ Out Periotome #5
FDA UDI
Class IActive
Tatum Surgical IP Press Fit Abutment IP PN 4.5 Blank
FDA UDI
Class IIActive
TatumSurgical/Small Ball Post Small Ball Post/4.0mmx5mm
FDA UDI
Class IIUnknown
TatumSurgical/Tapered Implant Tapered/5.0x14
FDA UDI
Class IIActive
Tatum Surgical/Hand Tool Hand Tool / HT.23
FDA UDI
Class IActive
TatumSurgical/6.0-8.0x3.0mm Integrity Platform Switch Healing Cuff 6.0-8.0x3.0mm Integrity PS-HC
FDA UDI
Class IIActive
TatumSurgical/Tapered Implant Tapered/5.0x17
FDA UDI
Class IIActive
Scalpel Handle - Adjustable Scalpel Handle - Adjustable
FDA UDI
Class IActive
Tatum Surgical-Osteotome Osteotome Tapered 4.0 x 12 Offset
FDA UDI
Class IActive
Tatum Surgical-Osteotome OsteotomeZ RB 6.0
FDA UDI
Class IActive
Tatum Sinus Retractor Kit Tatum Sinus Retractor Kit
FDA UDI
Class IActive
Tatum Surgical-Osteotome OsteotomeZ RB 4.0
FDA UDI
Class IActive
TatumSurgical/3.7x1.0mm Integrity Implant Healing Cuff 3.7x1.0mm Integrity Implant Healing Cuff
FDA UDI
Class IIActive
Tatum Surgical/IP Healing Plug IP Healing Plug
FDA UDI
Class IIActive
TatumSurgical/7.0x5.0mm Integrity Implant Healing Cuff 7.0x5.0mm Integrity Implant Healing Cuff
FDA UDI
Class IIActive
Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5 PITI-3.7-4.5 (30°) PS+1.5
FDA UDI
Class IIUnknown
Brasseler TTAP 5.0x14
FDA UDI
Class IActive
TatumSurgical/Ball Post for Integrity 3.7-4.5, 3.7-4.5 x 5.0mm Cuff Height 3.7-4.5 x 5mm Integrity ball post
FDA UDI
Class IIActive
ITL Dental HTRAL latch grip .050 driver
FDA UDI
Class IActive
TatumSurgical/6.0x3.0mm Integrity Implant Healing Cuff 6.0x3.0mm Integrity Implant Healing Cuff
FDA UDI
Class IIActive
Tatum Surgical/ IP-BP 4.5mm Medium Ball Post Attachment IP-BP-4.5xSB-M
FDA UDI
Class IIActive
Tatum Surgical/Hand Tool Hand Tool / HT.28
FDA UDI
Class IUnknown
Tatum Surgical/Ti-Base PITI 6.0-8.0 Ti Base, 7mm tall for ITI 6.0-8.0 Implants
FDA UDI
Class IIUnknown
Tatum Surgical/One Piece small ball head implant One Piece/8.0x14SB
FDA UDI
Class IIUnknown
Tatum Surgical/Integrity Implant Integrity/4.0 x 11
FDA UDI
Class IIActive
Tatum Surgical/Platform Switch Post PITI 6.0-8.0 (0°) Degree Platform Switch Post, 7mm tall for ITI 6.0-8.0 Implants
FDA UDI
Class IIActive
Tatum Surgical-Osteotome OsteotomeZ RP 3.5
FDA UDI
Class IActive
Tatum Surgical-Osteotome OsteotomeZ RT 3.0
FDA UDI
Class IActive
TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0-8.0 x 3.0mm Cuff Height 6.0-8.0 x 3mm Integrity ball post
FDA UDI
Class IIActive
Tatum Surgical-Integrity Implant 5.0x20mm, Bone Level ITI-B 5.0x20
FDA UDI
Class IIActive
TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0 x 3.0mm Cuff Height 6.0 x 3mm Integrity ball post
FDA UDI
Class IIUnknown
TatumSurgical/5.0x5.0mm Integrity Implant Healing Cuff 5.0x5.0mm Integrity Implant Healing Cuff
FDA UDI
Class IIActive
Tatum Surgical-Osteotome Osteotome Tapered 3.0 x 15 Offset
FDA UDI
Class IActive
Tatum Surgical-Analog Analog (SB) 5x14
FDA UDI
Class IUnknown
Tatum Post Guide 50° Post Guide 50°
FDA UDI
Class IActive
Seldin Retractor Seldin #23 Mini Flat
FDA UDI
Class IActive

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