Identifiers
- 510(k) Number
- K211551 FDA 510(k)
- FDA Product Code
- NPM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Wishbone HA is a bone grafting material of animal source. It is used for dental applications to promote bone regeneration and support in surgical procedures.
The device is supplied as a sterile, single-use product. It is available in various sizes and is intended for use in dental surgical settings. Wishbone HA has received FDA 510(k) clearance with product code NPM.
Frequently asked questions
What is Wishbone HA used for?
Wishbone HA is used for dental applications to promote bone regeneration and support in surgical procedures, as it is a bone grafting material derived from animal source intended to aid in bone repair.
How is Wishbone HA supplied and is it sterile or reusable?
Wishbone HA is supplied as a sterile, single-use product, meaning it is provided in a sterile condition and intended for one-time use only during dental surgical procedures to prevent cross-contamination.
What sizes or models is Wishbone HA available in?
Wishbone HA is available in various sizes, though specific dimensions are not detailed in the provided data; the device is offered in multiple size options to suit different dental surgical needs.
What regulatory pathway was used for Wishbone HA?
Wishbone HA received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device, with product code NPM and regulation number 872.3930.
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 | K211551 | Class II | Active |
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Manufacturer
- Manufacturer
- Wishbone SA
Sources (1)
- FDA 510(k) K211551 24 fields · synced Oct 1, 2026