TatumSurgical/Abutment (Post)

FDA UDI

Class II (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: TatumSurgical/Abutment (Post) FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Implant Abutment 5.0mm x 10 degree -5mm Height FDA UDI
Model / Reference: Abutment/5.0mm x 10 degree Post - Short FDA UDI
Description: Implant Abutment 5.0mm x 10 degree -5mm Height FDA UDI

Identifiers

Catalog Number: PN50.10S FDA UDI
Primary DI / UDI-DI: 00083208850103 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 5 Millimeter FDA UDI
Angle — 10 degree FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

TatumSurgical/Abutment (Post) by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Screw endosteal dental implant, two-piece.

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ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · 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 II	Pending data

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Manufacturer

Manufacturer: Suncoast Dental, Inc.

Sources (1)

FDA UDI 243205c3-2bf3-40bf-8e9a-6c165d295d69 36 fields · synced Jun 6, 2026