Si

FDA UDI

Class II (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name: SI FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI
Model / Reference: NSIR7008S FDA UDI
Description: Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809457201617 FDA UDI
510(k) Number: K160106 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 8.5 Millimeter FDA UDI
Outer Diameter — 7.0 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Si by Shinhung MST Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160106 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Shinhung MST Co., Ltd.

Sources (1)

FDA UDI fc78f8a4-b2ad-4565-8b85-2cab183b67b3 37 fields · synced Jun 1, 2026