K233921 is an FDA 510(k) clearance for the Luvis Chair (LC700C). This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 6, 2024, 268 days after receiving the submission on December 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K233921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2023 |
| Decision Date | September 06, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |