Tatum Surgical-Ball Post

FDA UDI

Class II (US FDA UDI)

by Suncoast Dental, Inc.

Identity

Trade Name: Tatum Surgical-Ball Post FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Large Ball Post 4.0mm Diameter x 3mm tissue cuff height FDA UDI
Model / Reference: Large Ball Post 4.0x3mm FDA UDI
Description: Large Ball Post 4.0mm Diameter x 3mm tissue cuff height FDA UDI

Identifiers

Catalog Number: BP 40.3.L (Hex) FDA UDI
Primary DI / UDI-DI: 00083208400339 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: Outer Diameter — 4.0 Millimeter FDA UDI
Height — 3 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Tatum Surgical-Ball Post by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 c4c14ad0-302b-424d-a31f-6b9b18a104e9 36 fields · synced Jun 6, 2026