K243130 is an FDA 510(k) clearance for the Integral Dental Unit. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Guangdong Yadeng Medical Apparatus Co., Ltd., (Foshan, CN). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K243130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 27, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |