PM2002 CC and PM2002 Ec
FDA 510(k) K904948 · Planmeca USA, Inc.
510(k) numberK904948
Submission
- Device name
- PM2002 CC and PM2002 Ec
- Applicant
- Planmeca USA, Inc.
Finland, FI - Received
- November 1, 1990
- Decision date
- January 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional | Lakong Medical Devices Co., Ltd. | 08/07/2026SE |
| K251626 | Midmark Dental Delivery SystemEIA · Traditional | Midmark Corporation | 11/03/2025SE |
| K251491 | K5 Cart, K5 Mount, K5 SwingEIA · Special | Osstem Implant Company., Ltd. Chair Business | 07/17/2025SE |
| K243130 | Integral Dental UnitEIA · Traditional | Guangdong Yadeng Medical Apparatus Co., Ltd., | 06/27/2025SE |
| K242611 | Integral Dental UnitsEIA · Traditional | Mipont Medical Equipment Co., Ltd. | 05/27/2025SE |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusEIA · Traditional | Dci International, LLC | 02/19/2025SE |
| K242404 | BDC Dental UnitEIA · Traditional | Bdc Dental Corporation , Ltd. | 02/07/2025SE |
| K231297 | Firstar Dental UnitEIA · Traditional | Firstar Dental Company | 01/27/2025SE |
| K233805 | K5EIA · Traditional | Osstem Implant Co., Ltd. Chair Business | 09/03/2024SE |
| K240754 | N2EIA · Special | Megagen Implant Co., Ltd. | 03/21/2024SE |
More from Megagen Implant Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K111361 | Planmed Nuance ExcelMUE · Traditional | 09/23/2011SE |
| K081699 | Planmeca SovereignEIA · Traditional | 08/29/2008SE |
| K923534 | PM2002 ProlineKLC · Traditional | 01/31/1994SE |
| 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 |
| 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 CC and PM2002 Ec cleared by the FDA?
PM2002 CC and PM2002 Ec (K904948) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 90 days after the submission was received.
What is the product code of K904948?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.