Osung Mnd

FDA UDI

Class II (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental impression material syringe, reusable FDA UDI
Device Name: A non-sterile, hand-held manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device. FDA UDI
Model / Reference: GMIJ43 FDA UDI
Description: A non-sterile, hand-held manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075624994 FDA UDI
FDA Product Code: EJI FDA UDI
GMDN Term: Dental impression material syringe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6770 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 impression material syringe, reusable

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

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MASTER-DENT — DENTONICS, INC.
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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 II	Pending data

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Manufacturer

Manufacturer: Osung Mnd Co., Ltd.

Sources (1)

FDA UDI bf031500-3080-4fba-b209-d91b7b9de516 33 fields · synced May 29, 2026