Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental mirror, reusable FDA UDI
Device Name: A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. FDA UDI
Model / Reference: DME4 FDA UDI
Description: A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075602992 FDA UDI
FDA Product Code: EAX FDA UDI
GMDN Term: Dental mirror, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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 mirror, reusable

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

Similar devices

Also classified as Dental mirror, reusable.

MIRROR — KLS-Martin L.P. · Class I
TUCKER SCALER-B7-U15H — W.H. Holden, Inc. · Class I
MOUTH MIRROR HANDLE, CONE SOCKET, HANDFORM, STAINLESS STEEL — W.H. Holden, Inc. · Class I
ZOLL-DENTAL — Zoll-Dental · Class I
Riofoto™ Mirrors — Ortho Organizers, Inc. · Class I
MIRROR — KLS-Martin L.P. · Class I
Plasdent — PLASDENT CORP. · Class I
Henry Schein — HENRY SCHEIN, 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

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Manufacturer

Manufacturer: Osung Mnd Co., Ltd.

Sources (1)

FDA UDI 1ca4910f-fd0b-4285-a748-2aab968c0fdc 33 fields · synced May 30, 2026