Identifiers
- 510(k) Number
- K240912 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
- Models / Variants
- Models HT-plus FDA 510(k)ST FDA 510(k)SHT FDA 510(k)UT FDA 510(k)3D-Pro FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dental Zirconia Block - SHT by Anhui Miisen Intelligence Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 5 models
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 | K240912 | Class II | Active |
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Manufacturer
- Manufacturer
- Anhui Miisen Intelligence Technology Co., Ltd.
Sources (1)
- FDA 510(k) K240912 24 fields · synced Jun 18, 2026