Neobiotech Implant System

FDA UDI

Class I (US FDA UDI)

by Neobiotech. co., ltd

Identity

Trade Name: Neobiotech Implant System FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Ø2.2, L:8.5mm FDA UDI
Model / Reference: SGD2208 FDA UDI
Description: Ø2.2, L:8.5mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08809815655960 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Introducing the Neobiotech Implant System, a high-quality dental implant fixture/appliance for safe and effective oral surgery. This reusable drill bit is designed to provide precise control and ease of use in various surgical procedures. With its durable construction and adjustable length, it's perfect for a variety of implants.

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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 I	Pending data

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Manufacturer

Manufacturer: Neobiotech. co., ltd

Sources (1)

FDA UDI 279d8747-1772-4804-ba2b-bbe583fcea34 33 fields · synced Jul 31, 2026