Radix Anchor

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Radix Anchor FDA UDI
Generic Name: Fixture/appliance dental drill bit, single-use FDA UDI
Device Name: Radix-Anchor Drills Root Facer Type RA Size 2 FDA UDI
Model / Reference: 671631 FDA UDI
Description: Radix-Anchor Drills Root Facer Type RA Size 2 FDA UDI

Identifiers

Catalog Number: 671631 FDA UDI
Primary DI / UDI-DI: D7166716311 FDA UDI
FDA Product Code: ELR FDA UDI
GMDN Term: Fixture/appliance dental drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

The Radix Anchor Drills Root Facer Type RA Size 2 is a dental device used for creating channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is typically available in a set of graduated sizes and various forms and functions, making it suitable for single-use applications.

Similar devices

Also classified as Fixture/appliance dental drill bit, single-use.

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Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
XP-I SLA Fixture — sewon medix Inc. · Class II

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: Tulsa Dental Products Llc

Sources (1)

FDA UDI 03d5f759-798f-4b5f-9307-e1decce09386 34 fields · synced Jul 26, 2026