Dentatus L Set
FDA 510(k) K863016 · Sds Dental, Inc.
510(k) numberK863016
Submission
- Device name
- Dentatus L Set
- Applicant
- Sds Dental, Inc.
Washington, DC, US - Received
- August 8, 1986
- Decision date
- October 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KLC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233921 | Luvis Chair (LC700C)KLC · Traditional | Dentis Co., Ltd. | 09/06/2024SE |
| 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 |
More from Planmeca USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990546 | Delsonic 2000ELC · Traditional | 11/05/1999SE |
| K990545 | Jetsonic 2000KOJ · Traditional | 08/11/1999SE |
| K964619 | Delivery System(Sds 1400 Xl)/Delivery System CUSPIDOR(SDS1450,SDS1650 XL)EIA · Traditional | 01/22/1997SE |
| K902865 | Baumer Surgical TableBWN · Traditional | 09/10/1990SE |
| K902864 | Surgical Lighting-Centra 450FSY · Traditional | 09/10/1990SE |
| K863011 | Dentatus Ls/Euroflex F-Iv/Isolight Reflect/Cm-Ii · Traditional | 10/10/1986SE |
| K863021 | Cm-Ii, Cm-I Water UnitEIA · Traditional | 10/01/1986SE |
| K863015 | Isoprat C-Iii Set/Isocart III Auxiliary Unit · Traditional | 10/01/1986SE |
| K863014 | Isoprat F-Iii Set/Isolax Chair · Traditional | 10/01/1986SE |
| K863013 | Isolax Pedal Set · Traditional | 10/01/1986SE |
Questions and answers
When was Dentatus L Set cleared by the FDA?
Dentatus L Set (K863016) received a 510(k) decision of Substantially Equivalent on October 1, 1986, 54 days after the submission was received.
What is the product code of K863016?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.