Initial Drill

FDA UDI

Class I (US FDA UDI)

by POINTIMPLANT Co., Ltd.

Identity

Trade Name: Initial Drill FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Model / Reference: NID3010 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800011265588 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

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

MRI Safety

MR Conditional FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Initial Drill by POINTIMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: POINTIMPLANT Co., Ltd.

Sources (1)

FDA UDI 2411c562-2a6e-4da8-a985-c499ebaf021f 32 fields · synced May 31, 2026