Kavo Systematica 1060
FDA 510(k) K940950 · Kavo America
510(k) numberK940950
Submission
- Device name
- Kavo Systematica 1060
- Applicant
- Kavo America
Lake Zurich, IL, US - Received
- February 28, 1994
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K971063 | Optima Plus E Dental Chair; a Dental Chair; Excel ChairKLC · Traditional | King Dental Corp. | 06/03/1997SE |
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| K942870 | Ultima 2 Dental ChairKLC · Traditional | Dentech Corp. | 02/27/1995SE |
| 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 |
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| K051909 | DiagnodentNBL · Traditional | 10/21/2005SE |
| K030146 | Kavo Key Laser 1242 and Kavo Key Laser 1243+NVK · Traditional | 08/03/2005SE |
| K042394 | Diagnodent Perio Tip (Accessory)NBL · Traditional | 08/02/2005SE |
| K050744 | Kavo Ergocom/ErgocamLLZ · Traditional | 04/21/2005SE |
| K050019 | In Exam Intraoral Dental X-Ray SystemEHD · Traditional | 01/31/2005SE |
| K042872 | Rondoflex Plus 360KOJ · Special | 11/23/2004SE |
| K033221 | Kavo Everest Zh-BlankEIH · Special | 10/28/2003SE |
Questions and answers
When was Kavo Systematica 1060 cleared by the FDA?
Kavo Systematica 1060 (K940950) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 304 days after the submission was received.
What is the product code of K940950?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.