Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name: OSUNG MND FDA UDI
Generic Name: Dental soft-tissue coring punch, reusable FDA UDI
Device Name: A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device. FDA UDI
Model / Reference: TPH35S FDA UDI
Description: A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800075612762 FDA UDI
FDA Product Code: EME FDA UDI
GMDN Term: Dental soft-tissue coring punch, 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 soft-tissue coring punch, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Osung Mnd Co., Ltd.

Sources (1)

FDA UDI fa77efb3-7bc1-42e9-a454-3600093899ff 33 fields · synced Jun 1, 2026