Sm3

FDA UDI

Class II (US FDA UDI)

by Osstem Implant Co., Ltd._Gasan Branch

Identity

Trade Name: SM3 FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: Motor and cord set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. FDA UDI
Model / Reference: SL FDA UDI
Description: Motor and cord set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800000995236 FDA UDI
FDA Product Code: KMW FDA UDI
EGS FDA UDI
EBW FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 FDA UDI
872.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant system

Sm3 by Osstem Implant Co., Ltd._Gasan Branch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

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Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
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Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II

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: Osstem Implant Co., Ltd._Gasan Branch

Sources (1)

FDA UDI 428fc75b-c874-4bff-981e-8ab732d982c8 33 fields · synced May 30, 2026