General Purpose Dental Tray
FDA 510(k) K962527 · Medcare Medical Group, Inc.
510(k) numberK962527
Submission
- Device name
- General Purpose Dental Tray
- Applicant
- Medcare Medical Group, Inc.
East Swanzey, NH, US - Received
- June 27, 1996
- Decision date
- August 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K973497 | HuberlocLJT · Traditional | 01/13/1998SE |
| K970152 | Biopsy TrayFRG · Traditional | 03/05/1997SN |
| K962849 | Catheter Insertion TrayLJS · Traditional | 10/07/1996SE |
| K961075 | Medcare Regional Anethesia KitCAZ · Traditional | 09/06/1996SEKD |
| K962328 | Single Use Instrument TrayFSM · Traditional | 08/09/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | 07/19/1996SE |
| K961167 | Medcare Tracheostomy Care TrayLRQ · Traditional | 07/02/1996SESK |
Questions and answers
When was General Purpose Dental Tray cleared by the FDA?
General Purpose Dental Tray (K962527) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 35 days after the submission was received.
What is the product code of K962527?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.