Immediate Molar

FDA UDI

Class I (US FDA UDI)

by Biomet 3i, Llc

Identity

Trade Name: Immediate Molar FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Immediate Molar Tapered Drill T3® PRO 4.4mmD FDA UDI
Model / Reference: IMDR44T3P FDA UDI
Description: Immediate Molar Tapered Drill T3® PRO 4.4mmD FDA UDI

Identifiers

Primary DI / UDI-DI: 00844868047964 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

Yes

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

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Fixture/appliance dental drill bit, reusable

The Immediate Molar is a dental fixture/appliance device designed for creating channels of appropriate depth and diameter in bone (osteotomy) to facilitate the implantation of a dental fixture/appliance. Reusable, manual or power tool handpiece allows for rotation. The device has various forms and functions, including guide, pilot, twist, cortical, conical drill bits.

Similar devices

Also classified as Fixture/appliance dental drill bit, reusable.

Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
Prima Plus — Keystone Dental Inc. · Class I
FTN Tapered Drill — DIO Corporation · Class I
Prima — Keystone Dental Inc. · Class I
Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
Stopper Drill — Megagen Implant Co. Ltd · Class I

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: Biomet 3i, Llc

Sources (1)

FDA UDI 3e00be15-c397-4dec-a7b3-2ee42e341588 34 fields · synced Jul 30, 2026