Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Diamond dental bur, single-use FDA UDI
Device Name: A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device. FDA UDI
Model / Reference: 137.14F1 FDA UDI
Description: A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075617682 FDA UDI
FDA Product Code: DZP FDA UDI
GMDN Term: Diamond dental bur, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4535 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, single-use

A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, designed for use in dentistry to cut hard structures such as teeth or bone. This single-use device is available in various shapes and is intended for fabrication of dental devices. It is also suitable for cutting hard metals, plastics, porcelains, and similar materials.

Similar devices

Also classified as Diamond dental bur, single-use.

Brasseler USA — Peter Brasseler Holdings, LLC
PIRANHA DIAMOND — SS White Burs LLC · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Brasseler USA — Peter Brasseler Holdings, LLC
Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Brasseler USA — Peter Brasseler Holdings, LLC
Brasseler USA — Peter Brasseler Holdings, LLC
CleanCut™ Extended Use Diamond FG 801-021C| — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · 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: Osung Mnd Co., Ltd.

Sources (1)

FDA UDI c9915a3a-4ce6-48b5-9381-a9b54c4c7ddf 33 fields · synced Jun 28, 2026