BellaTek

FDA UDI

Class II (US FDA UDI)

by Biomet 3i, Llc

Identity

Trade Name: BellaTek FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: TSV® BELLATEK® EXPRESS ABUTMENT 3.5MM (D) 4.75MM (H) HEXED FDA UDI
Model / Reference: TE351 FDA UDI
Description: TSV® BELLATEK® EXPRESS ABUTMENT 3.5MM (D) 4.75MM (H) HEXED FDA UDI

Identifiers

Primary DI / UDI-DI: 00844868043775 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 4.75 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

Category: Dental implant suprastructure, permanent, preformed

BellaTek is a commercially available prefabricated dental implant system designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration. It consists of one or more structural components, including abutments, bars, and coping rings, which are glued to prostheses and/or devices that can be replaced during cleaning cycles.

SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
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Diamodent — Diamodent · Class II
Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
GS System — OSSTEM IMPLANT Co., Ltd. · Class II
Temporary Abutment — Cybermed Inc. · Class II
EZ Post — Megagen Implant Co. Ltd · 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: Biomet 3i, Llc

Sources (1)

FDA UDI c76ca315-e399-4782-bde7-53761da5ace3 34 fields · synced Jul 3, 2026

BellaTek

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)