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Art-M3 25k, Model M3-1-Art2-A1 +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K994203
Identifiers
- 510(k) Number
- K994203 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
- Models / Variants
- Art-M3 25k, Model M3-1-Art2-A1 FDA 510(k)Art-M3 30k, Model M3-1-Art3-A1 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Art-M3 25k, Model M3-1-Art2-A1 +1 more model by Bonart Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K994203 | Class II | Active |
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Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA 510(k) K994203 24 fields · synced Jun 18, 2026