Neoss Implant System 03.25
FDA 510(k)Class II (US FDA 510(k))
by Neoss, Ltd.
Identifiers
- 510(k) Number
- K090452 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 Neoss Implant System 03.25 is a dental implant system designed for use in dental procedures. It is categorized under product code DZE and is intended for dental applications as indicated by its advisory committee designation.
The system is supplied by Neoss, Ltd. and received FDA 510(k) clearance with decision code SESE on May 22, 2009. It is manufactured in Alexandria, VA, and is available in various sizes including model 03.25. The device is intended for single-use or reusable applications depending on the specific implant type.
Frequently asked questions
What is the Neoss Implant System 03.25 used for?
The Neoss Implant System 03.25 is a dental implant system designed for use in dental procedures. It is categorized under product code DZE and is intended for dental applications as indicated by its advisory committee designation.
Is the Neoss Implant System 03.25 single-use or reusable?
The device is intended for single-use or reusable applications depending on the specific implant type. This flexibility allows clinicians to choose the appropriate usage based on their clinical needs and the specific implant model being used.
What regulatory approvals does the Neoss Implant System 03.25 have?
The Neoss Implant System 03.25 received FDA 510(k) clearance with decision code SESE on May 22, 2009. It was manufactured in Alexandria, VA, and is categorized under product code DZE with a dental advisory committee designation.
What sizes and models are available for the Neoss Implant System?
The Neoss Implant System is available in various sizes including model 03.25. This range of options allows clinicians to select the most appropriate implant size for their specific clinical requirements and patient anatomy.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090452 | Class II | Active |
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Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (1)
- FDA 510(k) K090452 24 fields · synced Sep 21, 2026