Shandong Huge Dental Material
Medical device makerAI in ChinaAI. FDA records under its name, each linked to the record.
- 510(k) clearances: 9
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 6, 2026 | Denture BaseK260376 · EBI | 510(k) clearances |
| Apr 9, 2026 | Eternal Art Porcelain PowdersK260067 · EIH | 510(k) clearances |
| Aug 1, 2025 | NOBILCAM IMPAK DiscK251252 · MQC | 510(k) clearances |
| Aug 12, 2022 | Denture Base PolymersK220680 · EBI | 510(k) clearances |
| Mar 4, 2022 | Flexible BlockK213994 · EBI | 510(k) clearances |
| Sep 24, 2020 | A-Silicone for Bite RegistrationK201684 · ELW | 510(k) clearances |
| Apr 18, 2019 | Orthodontic ApplianceK181747 · NXC | 510(k) clearances |
| Mar 3, 2017 | Glass Ionomer CementK160345 · EMA | 510(k) clearances |
Canada and Imports
Matched by company nameNames and Identifiers
- Appears as
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built