PM2002 Proline
FDA 510(k) K923534 · Planmeca USA, Inc.
510(k) numberK923534
Submission
- Device name
- PM2002 Proline
- Applicant
- Planmeca USA, Inc.
Finland, FI - Received
- July 16, 1992
- Decision date
- January 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K925325 | A-Dec 2185 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
More from A-Dec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111361 | Planmed Nuance ExcelMUE · Traditional | 09/23/2011SE |
| K081699 | Planmeca SovereignEIA · Traditional | 08/29/2008SE |
| K923533 | AdmarkJAC · Traditional | 03/04/1993SE |
| K923462 | DelightEAZ · Traditional | 12/21/1992SE |
| K923461 | PM2002 Proline, PM2002 Proline EcKLC · Traditional | 12/21/1992SE |
| K904953 | Planmed SophieIZH · Traditional | 04/18/1991SE |
| K904948 | PM2002 CC and PM2002 EcEIA · Traditional | 01/30/1991SE |
| K904947 | PM2002 CC, Aristocrat and Aristocrat DeluxeBZG · Traditional | 01/30/1991SE |
| K864474 | Dental Radiographic 90, Model PM 2002 CC PanoramicEHD · Traditional | 11/26/1986SE |
| K842359 | Automatic Patient Chair PM2000 & a · Traditional | 09/19/1984SE |
Questions and answers
When was PM2002 Proline cleared by the FDA?
PM2002 Proline (K923534) received a 510(k) decision of Substantially Equivalent on January 31, 1994, 564 days after the submission was received.
What is the product code of K923534?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.