Neoss Implant System

FDA UDI

Class I (US FDA UDI)

by Neoss, Ltd.

Identity

Trade Name: Neoss Implant System FDA UDI
Generic Name: Fixture/appliance dental drill bit, single-use FDA UDI
Device Name: Neoss® Guide - Guide Key Ø4.9/5.1 FDA UDI
Model / Reference: 51170 FDA UDI
Description: Neoss® Guide - Guide Key Ø4.9/5.1 FDA UDI

Identifiers

Catalog Number: 51170 FDA UDI
Primary DI / UDI-DI: 05060440332982 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fixture/appliance dental drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

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

Category: Fixture/appliance dental drill bit, single-use

Neoss Implant System by Neoss, Ltd. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Neoss, Ltd.

Sources (1)

FDA UDI 01595303-64ee-470e-aec0-8e385e6744a3 35 fields · synced May 30, 2026