Zibone

FDA UDI

Class I (US FDA UDI)

by Coho Biomedical Technology Co., Ltd.

Identity

Trade Name: Zibone FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Zibone Zirconia Twist drill Diameter: 23 mm FDA UDI
Model / Reference: Zr-D2316 FDA UDI
Description: Zibone Zirconia Twist drill Diameter: 23 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 04710986430987 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Zibone by Coho Biomedical Technology 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: Coho Biomedical Technology Co., Ltd.

Sources (1)

FDA UDI 6b8faffa-2cd0-4050-9e20-17f2e44c420d 33 fields · synced May 31, 2026