Safetywand Disposable Handpiece
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023722 FDA 510(k)
- FDA Product Code
- EJI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6770 FDA 510(k)
- Regulation Number
- 872.6770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Safetywand Disposable Handpiece is a syringe and cartridge device designed for dental applications. It is intended to inject local anesthetic agents subcutaneously or intramuscularly.
This device is supplied as a sterile, single-use handpiece. It has received FDA 510(k) clearance under the regulation number 872.6770.
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: Safetywand Disposable Handpiece 510 (k) FDA Premarket Notification ..., FDA Browser - Cleared 510 (K) - SAFETYWAND DISPOSABLE HANDPIECE (K023722), Spintech, Inc. FDA 510 (k) Products 2022, Spintech, Inc. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023722 | Class II | Active |
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Manufacturer
- Manufacturer
- Spintech, Inc.
Sources (1)
- FDA 510(k) K023722 24 fields · synced Sep 27, 2026