Siemens Sirona(R) Dental Chair
FDA 510(k) K863484 · Pelton & Crane Co.
510(k) numberK863484
Submission
- Device name
- Siemens Sirona(R) Dental Chair
- Applicant
- Pelton & Crane Co.
Charlotte, NC, US - Received
- September 9, 1986
- Decision date
- September 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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.
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| K972249 | Orthophos Plus and Orthophos Plus/CdEHD · Traditional | 09/12/1997SE |
| K972168 | Sidexis Digital Radiography SystemEHD · Traditional | 09/05/1997SE |
| K945117 | DeltaFLE · Traditional | 02/28/1997SE |
| K962071 | Spirit S1/S2EIA · Traditional | 08/06/1996SE |
| K960819 | Heliodent DSEAP · Traditional | 03/29/1996SE |
| K950299 | Cerec 2ELW · Traditional | 05/23/1995SE |
| K946187 | Spirit II and Spirit Treatment CenterEIA · Traditional | 03/01/1995SE |
| K950030 | Heliodent MDEAP · Traditional | 02/03/1995SE |
Questions and answers
When was Siemens Sirona(R) Dental Chair cleared by the FDA?
Siemens Sirona(R) Dental Chair (K863484) received a 510(k) decision of Substantially Equivalent on September 19, 1986, 10 days after the submission was received.
What is the product code of K863484?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.