Identifiers
- 510(k) Number
- K112540 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 S-Mini Implant System is a dental implant system designed as a one-body mini implant (cement type) for use in situations with limited available space and minimal bone, such as in the anterior mandibular region. It is intended to provide a secure and predictable solution for dental implant placement.
The system is supplied as a surgical kit and is used in dental implant surgery. It received FDA 510(k) clearance (K112540) as substantially equivalent to a predicate device, with product code DZE and review by the Dental advisory committee. The device is manufactured by Neobiotech Co., Ltd. and is intended for use in clinical dental settings.
Frequently asked questions
What is the S-Mini Implant System used for?
The S-Mini Implant System is designed for dental implant placement in situations with limited available space and minimal bone, such as the anterior mandibular region, providing a secure and predictable solution where standard implants may not fit.
How is the S-Mini Implant System supplied and used?
The system is supplied as a surgical kit and is used in dental implant surgery by clinicians in clinical dental settings, intended for one-body cement-type mini implant placement.
Is the S-Mini Implant System a single-use or reusable device?
As a dental implant system intended for surgical placement, the S-Mini Implant System components are designed for single-use during implantation to ensure sterility and patient safety, consistent with standard dental implant protocols.
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: Neobiotech | S-Mini Kit, Neobiotech | S-Mini (Cemented Type), S-MINI IMPLANT | NeoBiotech USA: Dental Implants Across the United ..., S-Mini - Conical dental implant by Neobiotech | MedicalExpo, Neobiotech | S-Mini (Cemented Type)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112540 | Class II | Active |
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Manufacturer
- Manufacturer
- Neobiotech. co., ltd
- FDA Applicant
- Neobiotech Co., Ltd.
Sources (1)
- FDA 510(k) K112540 24 fields · synced Sep 24, 2026