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MS System (Provisional)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K072871

by Osstem Implant Co., Ltd.

Identifiers

510(k) Number
K072871 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MS System (Provisional) is a dental implant device designed for osseointegrated fixation in the jawbone. It is classified as a dental implant system, intended for use in reconstructive oral and maxillofacial surgery to restore function and aesthetics following tooth loss.

This system is supplied sterile for single-use and is regulated under FDA 510(k) clearance (K072871) and the EU Medical Device Regulation (MDR). It is intended for use in clinical settings by dental professionals, with no specific MRI safety restrictions noted. The device is distributed by Osstem Implant Co., Ltd., and its provisional status reflects an interim classification pending final regulatory confirmation.

Frequently asked questions

What types of clinical settings is the MS System (Provisional) intended for use in, and who can use it?

The MS System (Provisional) is designed exclusively for clinical use in reconstructive oral and maxillofacial surgery. It is intended for dental professionals, such as oral surgeons or periodontists, who specialize in dental implant procedures to restore function and aesthetics after tooth loss. The device is not intended for home use or non-professional administration.

Is the MS System (Provisional) reusable or single-use, and how is it supplied?

The MS System (Provisional) is supplied sterile for single-use only. This ensures patient safety and sterility, as it is intended for one-time surgical use in clinical settings. Reuse is not recommended or supported by the manufacturer.

Are there any specific storage requirements for the MS System (Provisional) before use?

While the provided data does not explicitly detail storage conditions, the device is supplied sterile for single-use, meaning it should be stored in a clean, dry environment protected from contamination until use. Standard sterile packaging precautions should be followed to maintain integrity until implantation.

What regulatory pathways does the MS System (Provisional) follow in the U.S. and EU?

In the U.S., the MS System (Provisional) is regulated under FDA 510(k) clearance (K072871), classified as substantially equivalent to a predicate device and reviewed by the Dental (DE) Advisory Committee. In the EU, it complies with the Medical Device Regulation (MDR), though no additional specifics about the MDR submission are provided. Both pathways confirm its classification as a dental implant system.

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

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Manufacturer

Manufacturer
Osstem Implant Co., Ltd.

Sources (2)

  • FDA 510(k) K072871 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026