Identifiers
- 510(k) Number
- K080594 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 (Narrow Ridge) is a dental implant system designed for the treatment of missing mandibular central and lateral incisors to support prosthetic devices such as artificial teeth. It features a one-body implant design where the implant and abutment are integrated, intended for placement at bone level in narrow anterior areas or edentulous ridges with limited bone width.
The system is supplied as a sterile, single-use device and is intended for use in dental surgical settings. It has received FDA 510(k) clearance under K080594 with product code DZE and is classified as substantially equivalent to a predicate device. Recommended placement torque is a maximum of 30 Ncm, and it is compatible with MS Kit instruments and SA or RBM surface treatments.
Frequently asked questions
What is the MS System (Narrow Ridge) used for?
The MS System (Narrow Ridge) is designed to replace missing mandibular central and lateral incisors by supporting prosthetic teeth. It is intended for placement in narrow anterior ridges or edentulous areas with limited bone width, where its one-body design integrates the implant and abutment for bone-level placement.
How is the MS System (Narrow Ridge) supplied and is it reusable?
The device is supplied as a sterile, single-use implant system, meaning each unit is individually packaged and sterilized for one surgical procedure only. It is not intended for cleaning, resterilization, or reuse due to risks of contamination, material degradation, and loss of structural integrity after initial use.
What regulatory pathway was used for the MS System (Narrow Ridge)?
The MS System (Narrow Ridge) received FDA 510(k) clearance under submission number K080594, demonstrating substantial equivalence to a predicate device. It is classified under product code DZE and was cleared via the traditional 510(k) pathway, not requiring premarket approval.
What instruments and surface treatments are compatible with the MS System (Narrow Ridge)?
The MS System (Narrow Ridge) is designed to be used with MS Kit surgical instruments for placement and is compatible with either SA (sandblasted and acid-etched) or RBM (resorbable blast media) surface treatments, which enhance osseointegration in narrow bone sites.
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. Sources consulted: PDF Surgical Manual MS Implant System - osstem.eu, PDF MS Implant - dev.osstem.eu, MS SYSTEM (NARROW RIDGE) (K080594) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080594 | Class II | Active |
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Manufacturer
- Manufacturer
- Osstem Implant Co., Ltd.
Sources (1)
- FDA 510(k) K080594 24 fields · synced Sep 26, 2026