K252789 is an FDA 510(k) clearance for the Glass Ceramic. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Shenzhen Xiangtong Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 8, 2025, 97 days after receiving the submission on September 2, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K252789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2025 |
| Decision Date | December 08, 2025 |
| Days to Decision | 97 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |