Fix'in

FDA UDI

Class I (US FDA UDI)

by Biotech Dental

Identity

Trade Name: FIX'IN FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Drill Ø1.1mm recipient site self-Drilling screw Ø1.5mm and Ø1.7mm FDA UDI
Model / Reference: PFS11 FDA UDI
Description: Drill Ø1.1mm recipient site self-Drilling screw Ø1.5mm and Ø1.7mm FDA UDI

Identifiers

Primary DI / UDI-DI: 03701045250098 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Fix'in by Biotech Dental — 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: Biotech Dental

Sources (1)

FDA UDI 110211c3-6e21-4085-be57-348a06a5127c 34 fields · synced May 29, 2026