Improved Dental Operating Light
FDA 510(k) K920017 · Den-Tal-Ez Mfg Co., Inc.
510(k) numberK920017
Submission
- Device name
- Improved Dental Operating Light
- Applicant
- Den-Tal-Ez Mfg Co., Inc.
Lancaster, PA, US - Received
- January 2, 1992
- Decision date
- March 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K925629 | Accessory to Improved Dental Operating LightEAZ · Traditional | 11/23/1993SE |
| K932824 | Evacuator, Oral CavityEIA · Traditional | 09/28/1993SE |
| K931204 | AS3000 Operative Dental Unit (Delivery System)EIA · Traditional | 07/08/1993SE |
| K920016 | Improved Dental ChairKLC · Traditional | 03/02/1992SE |
| K874294 | Autochuck AttachmentEFB · Traditional | 12/29/1987SE |
| K780469 | Panoramic X-Ray, DentalEHD · Traditional | 04/10/1978SE |
Questions and answers
When was Improved Dental Operating Light cleared by the FDA?
Improved Dental Operating Light (K920017) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 60 days after the submission was received.
What is the product code of K920017?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.