US SA Implant System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161103Ref ASS3W5008S28

by Osstem Implant Co., Ltd.

Identity

Device Name: SA Implant System EUDAMED
Model / Reference: ASS3W5008S28 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800209305874 EUDAMED
Basic UDI-DI: 88000406SAA5 EUDAMED
510(k) Number: K161103 FDA 510(k)
FDA Product Code: DZE FDA 510(k)
EMDN Code: P01020101 DENTAL IMPLANTS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3640 FDA 510(k)
Regulation Number: 872.3640 FDA 510(k)
Market of Registration: Czechia EUDAMED
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

The US SA Implant System is a dental implant device designed for osseointegrated fixation in the jawbone. It is intended for use as a replacement for missing natural teeth, providing a stable foundation for prosthetic crowns, bridges, or dentures.

This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the Traditional pathway with a Substantially Equivalent determination. It is categorized under the Dental advisory committee (DE) and is regulated under the Medical Device Reporting (MDR) framework, with a product code of DZE. The device is manufactured by Osstem Implant Co., Ltd., based in Busan, South Korea.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K161103	Class II	Active

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Manufacturer

Manufacturer: Osstem Implant Co., Ltd.

Sources (2)

FDA 510(k) K161103 24 fields · synced Sep 18, 2026
EUDAMED e1c9f1a7-92ef-4fe9-a939-55bb65d56bce 61 fields · synced Jul 15, 2026