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: Small Ball Post 4.5mm Diameter x 5mm tissue cuff height FDA UDI
Model / Reference: Small Ball Post 4.5x5mm FDA UDI
Description: Small Ball Post 4.5mm Diameter x 5mm tissue cuff height FDA UDI

Identifiers

Catalog Number: BP 45.5.S (Hex) FDA UDI
Primary DI / UDI-DI: 00083208450556 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 — 4.5 Millimeter FDA UDI
Height — 5 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

Similar devices

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

ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
LW Solid Abutment — Ossvis Co., Ltd. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Suncoast Dental, Inc.

Sources (1)

FDA UDI 22c0acee-a39c-4eb3-aca9-55359b83c8c9 36 fields · synced May 31, 2026