Luvis Chair (LC700C)
FDA 510(k) K233921 · Dentis Co., Ltd.
510(k) numberK233921
Submission
- Device name
- Luvis Chair (LC700C)
- Applicant
- Dentis Co., Ltd.
Daegu, KR - Received
- December 13, 2023
- Decision date
- September 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K151987 | DCI Edge Dental Chair with Operative UnitKLC · Traditional | Dci | 06/01/2016SE |
| K071353 | Foshion Chair Mounted Dental, Model FJ48CKLC · Traditional | Shanghai Foshion Medical Instruments Co., Ltd. | 12/14/2007SE |
| K971063 | Optima Plus E Dental Chair; a Dental Chair; Excel ChairKLC · Traditional | King Dental Corp. | 06/03/1997SE |
| K963209 | Prostyle CompactKLC · Traditional | Planmeca Oy | 10/24/1996SE |
| K942870 | Ultima 2 Dental ChairKLC · Traditional | Dentech Corp. | 02/27/1995SE |
| K940950 | Kavo Systematica 1060KLC · Traditional | Kavo America | 12/29/1994SE |
| K925567 | E 4000 Dental Operating ChairKLC · Traditional | Dentalez Group | 03/10/1994SE |
| K925119 | A-Dec 1040 ChairKLC · Traditional | A-Dec, Inc. | 01/31/1994SE |
| K923534 | PM2002 ProlineKLC · Traditional | Planmeca USA, Inc. | 01/31/1994SE |
| K925325 | A-Dec 2185 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
More from A-Dec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K241063 | s-Clean ScanHealing AbutmentNHA · Traditional | 07/25/2024SE |
| K240511 | Dentis s-Clean SQ-SL FixtureDZE · Traditional | 05/20/2024SE |
| K233544 | MesheetNXC · Traditional | 02/22/2024SE |
| K230126 | Dentis s-Clean Regular AbutmentNHA · Traditional | 08/04/2023SE |
| K230307 | Dentis i-Clean SystemNHA · Traditional | 07/11/2023SE |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional | 05/25/2023SE |
| K230523 | s-Clean Link Abutment NarrowNHA · Traditional | 05/24/2023SE |
| K230203 | Dentis I-FIX AbutmentNHA · Traditional | 05/03/2023SE |
Questions and answers
When was Luvis Chair (LC700C) cleared by the FDA?
Luvis Chair (LC700C) (K233921) received a 510(k) decision of Substantially Equivalent on September 6, 2024, 268 days after the submission was received.
What is the product code of K233921?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.