Si

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name: SI FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Device Name: This product is used to implement fixture, abutment of oral cavity in impression acquisition and work model during dental implant procedure. FDA UDI
Model / Reference: SBCN5043H FDA UDI
Description: This product is used to implement fixture, abutment of oral cavity in impression acquisition and work model during dental implant procedure. FDA UDI

Identifiers

Primary DI / UDI-DI: 08806343906274 FDA UDI
FDA Product Code: EGG FDA UDI
GMDN Term: Dental implant suprastructure kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3165 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Dental implant suprastructure kit

Si 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 4d131db6-ee6a-45c8-ab3f-20b5babcb0b5 35 fields · synced May 31, 2026