Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental abrasive strip, single-use FDA UDI
Device Name: A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device. FDA UDI
Model / Reference: SRTVD90H FDA UDI
Description: A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075622136 FDA UDI
FDA Product Code: EHM FDA UDI
GMDN Term: Dental abrasive strip, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive strip, single-use

Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental abrasive strip, single-use.

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STEEL ABRASIVE STRIPS, 6 mm, double side coated, medium grits — Produits dentaires S.A. · Class I
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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: Osung Mnd Co., Ltd.

Sources (1)

FDA UDI 88362b28-17cd-4052-b33c-124b83d734cd 33 fields · synced Jun 6, 2026