ever GUIDE KIT

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name: ever GUIDE KIT FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: A dental implant surgical drill used to install dental implant fixtures. It is used to correct drill path deviation and form the implantation path and depth according to the fixture length in extraction cases. FDA UDI
Model / Reference: GLD2607 FDA UDI
Description: A dental implant surgical drill used to install dental implant fixtures. It is used to correct drill path deviation and form the implantation path and depth according to the fixture length in extraction cases. FDA UDI

Identifiers

Primary DI / UDI-DI: 08806343924483 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

ever GUIDE KIT by Shinhung MST 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: Shinhung MST Co., Ltd.

Sources (1)

FDA UDI 8b6d59e1-fbc1-41aa-80c2-18519225bc22 35 fields · synced May 31, 2026