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Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name
OSUNG MND FDA UDI
Generic Name
Rubber dam kit FDA UDI
Device Name
A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. This is a reusable device. FDA UDI
Model / Reference
RDSET FDA UDI
Description
A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI
08800075621320 FDA UDI
FDA Product Code
EEF FDA UDI
GMDN Term
Rubber dam kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

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: Rubber dam kit

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

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Manufacturer

Manufacturer
Osung Mnd Co., Ltd.

Sources (1)

  • FDA UDI 74534ff6-3ecd-46e1-96ba-11e2e4a3f87c 33 fields · synced Jun 8, 2026