evertis

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name: evertis FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Device Name: Bite Imp. Coping Φ5.0 G/H2.0 H4 Cross-fit RC/Straumann Used when taking impressions to make Straumann BLT prostheses. FDA UDI
Model / Reference: TBBCR5042R FDA UDI
Description: Bite Imp. Coping Φ5.0 G/H2.0 H4 Cross-fit RC/Straumann Used when taking impressions to make Straumann BLT prostheses. FDA UDI

Identifiers

Primary DI / UDI-DI: 08806343920072 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

evertis 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 062814f3-3eb1-4702-a28f-e0601f5feeaa 35 fields · synced May 30, 2026