Tatum One Piece Implant Kit

FDA UDI

Class I (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Tatum One Piece Implant Kit FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: Tatum One Piece Implant kit: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14. HT.02, 12, 13, 14, 15, 20, 21, 31 & 32. Tatum Ratchet. Autoclaveable Cassette/Container for all pieces. FDA UDI
Model / Reference: Standard One Piece Implant Kit 3.0-3.5 FDA UDI
Description: Tatum One Piece Implant kit: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14. HT.02, 12, 13, 14, 15, 20, 21, 31 & 32. Tatum Ratchet. Autoclaveable Cassette/Container for all pieces. FDA UDI

Identifiers

Catalog Number: ASY One-Piece Kit Base FDA UDI
Primary DI / UDI-DI: 00083208111112 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant system

Tatum One Piece Implant Kit by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
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TRI — Tri Dental Implants Int. AG · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Suncoast Dental, Inc.

Sources (1)

FDA UDI 8e0771fd-be81-4c59-addc-6904083a7ee1 35 fields · synced Jun 1, 2026