Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental material heater plate FDA UDI
Device Name: A non-powered component of a dental material heater designed to conduct heat from the heater’s heating element to a container holding a dental material/substance (e.g., composite resin, root canal cleaning solution, local anaesthetic agent). It is typically in the form of a metal block which incorporates holders of different shapes designed to accept specific devices/containers (e.g., vials, syringes, cartridges) for heating; it may include a cover. This is a reusable device. FDA UDI
Model / Reference: ARR1 FDA UDI
Description: A non-powered component of a dental material heater designed to conduct heat from the heater’s heating element to a container holding a dental material/substance (e.g., composite resin, root canal cleaning solution, local anaesthetic agent). It is typically in the form of a metal block which incorporates holders of different shapes designed to accept specific devices/containers (e.g., vials, syringes, cartridges) for heating; it may include a cover. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075626370 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental material heater plate FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 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 material heater plate

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

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 289da701-0544-420c-adfb-2d55054766ae 33 fields · synced May 30, 2026