NR Line

FDA UDI

Class I (US FDA UDI)

by Dentium Co., Ltd.

Identity

Trade Name: NR Line FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Accessories, Implant, Dental, Endosseous FDA UDI
Model / Reference: GXCS5029W FDA UDI
Description: Accessories, Implant, Dental, Endosseous FDA UDI

Identifiers

Catalog Number: GXCS5029W FDA UDI
Primary DI / UDI-DI: 08809544903561 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 28 Millimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI

Category: Fixture/appliance dental drill bit, reusable

NR Line by Dentium Co., 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: Dentium Co., Ltd.

Sources (1)

FDA UDI 054c69f4-e292-4eb0-8b7a-98592b99d5cf 36 fields · synced Jun 1, 2026