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SUNCOAST DENTAL, INC.

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: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000114355
DUNS Number: —

Catalogue (950)

Page 4 of 19

Device	Model / Reference	Registries	Class	Status
TatumSurgical/Screw Implant	Screw/5.0 x 20	FDA UDI	Class II	Active
Tatum Surgical-Osteotome	Osteotome Tapered 6.0 x 18 Straight	FDA UDI	Class I	Active
Retractor - Tongue and Cheek	Retractor T&C Set of 2	FDA UDI	Class I	Active
Tatum Surgical-Osteotome	Osteotome Tapered 3.5 x 21 Offset	FDA UDI	Class I	Active
Tatum Surgical/One Piece Crown and Bridge head implant	One Piece/7.0x17CB	FDA UDI	Class II	Unknown
TatumSurgical/Abutment (Integrity Post)	Abutment/7.0mm x 15 degree Integrity Post	FDA UDI	Class II	Unknown
Tatum Surgical/Platform Switch Post	PITI 6.0-8.0 (15°) PS Post, 7mm tall for ITI 6.0-8.0 Implants	FDA UDI	Class II	Active
Tatum Surgical/ITI 5.0 x 9mm	ITI 5.0 x 9mm	FDA UDI	Class II	Unknown
TatumSurgical/HC ITI 4.5mm Integrity-Delrin HC for Integrity 4.5mm Implant	Delrin Healing Cap for Integrity 4.5mm Implant	FDA UDI	Class II	Unknown
TatumSurgical/Tapered Implant	Tapered/8.0x14	FDA UDI	Class II	Active
Brasseler	TTAP 6.0x17	FDA UDI	Class I	Active
Tatum Surgical/Hand Tool	Hand Tool / HT.09L	FDA UDI	Class I	Active
TatumSurgical/6.0-8.0x1.0mm Integrity Platform Switch Healing Cuff	6.0-8.0x1.0mm Integrity PS-HC	FDA UDI	Class II	Active
Tatum Surgical-Osteotome	OsteoZ Offset RT 5.0N	FDA UDI	Class I	Active
Tatum Surgical-Analog	Analog (SB) 4.0x14	FDA UDI	Class I	Unknown
Tatum Surgical-Osteotome	OsteoZ Offset RP 4.0	FDA UDI	Class I	Active
Brasseler	TTAP 4.5x11	FDA UDI	Class I	Active
Tatum Surgical/One Piece Crown and Bridge head implant	One Piece/7.0x14CB	FDA UDI	Class II	Active
Tatum Surgical-Osteotome Kit	Tatum Universal Straight Osteotome Kit	FDA UDI	Class I	Active
Tatum Surgical-Osteotome	Osteotome Tapered 8.0 x 15 Offset	FDA UDI	Class I	Active
Tatum Surgical Bone Fixation Screw	Bone Fix Scw 1.5x15mm	FDA UDI	Class II	Active
TatumSurgical/HC ITI 6.0mm Integrity-Delrin HC for Integrity 6.0mm Implant	Delrin Healing Cap for Integrity 6.0mm Implant	FDA UDI	Class II	Unknown
Tatum Surgical/Ti-Base	PITI 3.7-4.5 Ti Base, 7mm tall for ITI 3.7-4.5 Implants	FDA UDI	Class II	Unknown
Tatum Surgical-Osteotome	Osteotome Tapered 3.5 x 12 Straight	FDA UDI	Class I	Active
TatumSurgical/Abutment (Integrity Post)	Abutment/7.0mm x 30 degree Integrity Post	FDA UDI	Class II	Unknown
TatumSurgical/Small Ball Post	Small Ball Post/5.0mmx1mm	FDA UDI	Class II	Unknown
TatumSurgical/Small Ball Post	Small Ball Post/5.0mmx3mm	FDA UDI	Class II	Unknown
TatumSurgical/ITO HC 3.5 (CB)-Delrin HC for 3.5 One-Piece (CB)	Delrin Healing Cap for 3.5 One-Piece (CB)	FDA UDI	Class II	Unknown
Tatum EZ Out Periotome Kit Box	Tatum EZ Out Periotome Kit Box	FDA UDI	Class I	Active
Tatum Surgical-Osteotome	OsteoZ Offset D2 5.5	FDA UDI	Class I	Active
Tatum Surgical/One Piece small ball head implant	One Piece/6.0 x 17SB	FDA UDI	Class II	Unknown
Tatum Surgical/Integrity Implant	Integrity/8.0x20	FDA UDI	Class II	Unknown
TatumSurgical/Abutment (Integrity Post)	Abutment/4.5mm x 30 degree Integrity Post	FDA UDI	Class II	Unknown
Tatum Surgical/One Piece small ball head implant	One Piece/4.5x14SB	FDA UDI	Class II	Unknown
TatumSurgical/Abutment (Post)	Abutment/4.5mm x 30 degree Post - Short	FDA UDI	Class II	Active
Brasseler	DR1.5TW	FDA UDI	Class I	Active
Retractor - Wangen	Retractor Wangen	FDA UDI	Class I	Active
Tatum Sinus Retractor	Tatum Sinus Retractor #4	FDA UDI	Class I	Active
Implant Spacers	Implant Spacers Set#1	FDA UDI	Class I	Active
TatumSurgical/3.7x5.0mm Integrity Implant Healing Cuff	3.7x5.0mm Integrity Implant Healing Cuff	FDA UDI	Class II	Active
Tatum Surgical/One Piece crown and bridge head implant	One Piece/5.0 x 17CB	FDA UDI	Class II	Active
Tatum Surgical/One Piece crown and bridge head implant	One Piece/3.0 x 14CB	FDA UDI	Class II	Active
Tatum Surgical/One Piece small ball head implant	One Piece/4.0x23SB	FDA UDI	Class II	Unknown
Tatum Post Guide 20°	Post Guide 20°	FDA UDI	Class I	Active
Tatum Surgical IP Press Fit Abutment	IP-PN-5.0 x 5 (CB) Abutment	FDA UDI	Class II	Active
TatumSurgical/Tapered Implant	Tapered/6.0x17	FDA UDI	Class II	Active
Tatum Surgical/One Piece Crown and Bridge Angled head implant	One Piece/3.0 x 14CBA	FDA UDI	Class II	Active
Tatum Surgical-Integrity Implant 8.0x17, Bone Level	ITI-B 8.0x17	FDA UDI	Class II	Active
Tatum Surgical-Osteotome	OsteotomeZ BS 6.0	FDA UDI	Class I	Active
Tatum Surgical-Integrity Platform Switching Abutment 5.0, 15°	PITI-5.0 (15°) PS+1.5	FDA UDI	Class II	Unknown

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