Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental amalgam well FDA UDI
Device Name: A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device. FDA UDI
Model / Reference: PLGWL1 FDA UDI
Description: A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075626325 FDA UDI
FDA Product Code: EKI FDA UDI
GMDN Term: Dental amalgam well 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 amalgam well

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 amalgam well.

Henry Schein — HENRY SCHEIN, INC. · Class I
PDT, Inc. — PDT, Inc. · Class I
Amalgam Well — HU-FRIEDY MFG CO., LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class II
PDT, Inc. — PDT, Inc. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, 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 0973666c-aa23-4387-afe9-b09dcda04210 33 fields · synced May 30, 2026