Nobel Biocare N1™

FDA UDI

Class I (US FDA UDI)

by Nobel Biocare AG

Identity

Trade Name: Nobel Biocare N1™ FDA UDI
Generic Name: Fixture/appliance dental drill bit, single-use FDA UDI
Device Name: Twist Step Drill Ø2.5/3.4 x 10-18mm FDA UDI
Model / Reference: 301421 FDA UDI
Description: Twist Step Drill Ø2.5/3.4 x 10-18mm FDA UDI

Identifiers

Catalog Number: 301421 FDA UDI
Primary DI / UDI-DI: 07332747185867 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.400 Millimeter FDA UDI
Length — 18.000 Millimeter FDA UDI

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

Nobel Biocare N1™ by Nobel Biocare AG — 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: Nobel Biocare AG

Sources (1)

FDA UDI 43b1d38d-3471-4d82-8feb-9b742e14ebbd 37 fields · synced May 31, 2026