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Speedex Light Body +4 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K242360
by Dent4You AG
Identifiers
- 510(k) Number
- K242360 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
- Models / Variants
- Speedex Light Body FDA 510(k)Speedex Medium FDA 510(k)Speedex Putty FDA 510(k)Speedex Putty Soft FDA 510(k)Speedex Universal Activator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Speedex Light Body +4 more models by Dent4You AG — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242360 | Class II | Active |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (1)
- FDA 510(k) K242360 24 fields · synced Jun 18, 2026