Belmont Unit, Model 6000 Series and 7500 Series
FDA 510(k) K983661 · Belmont Equipment Corp.
510(k) numberK983661
Submission
- Device name
- Belmont Unit, Model 6000 Series and 7500 Series
- Applicant
- Belmont Equipment Corp.
Somerset, NJ, US - Received
- October 19, 1998
- Decision date
- January 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K000799 | Belmont Unit, Model 2000 SeriesEIA · Traditional | 05/17/2000SE |
| K963699 | Belray/Model 096, Dental Intraoral X-RayEHD · Traditional | 12/23/1996SE |
| K900681 | Panoramic Model X-Caliber X-RayEAP · Traditional | 05/23/1990SE |
| K874238 | Model 2001 CP, Photon I, Dental, Intraoral X-RayEHD · Traditional | 12/07/1987SE |
| K870300 | Belmont, Podiatry X-Ray - Remex, Model PD75KPR · Traditional | 03/25/1987SE |
| K861328 | New Belmont Model, MC-5 Dental, Intraoral X-RayEAP · Traditional | 04/24/1986SE |
| K852019 | Belmont Autopan-Pan Oramic, 098E Cephalometric-RadEAP · Traditional | 06/05/1985SE |
| K844554 | Belmont Autopan-Panoramic 098 Cephalometric-RadiogIWZ · Traditional | 02/21/1985SE |
| K834279 | Acuray 071A Dental Intraoral X-RayEAP · Traditional | 12/29/1983SE |
| K832065 | Acuracy 071, Dental, Intraoral-X-RayEAP · Traditional | 09/12/1983SE |
Questions and answers
When was Belmont Unit, Model 6000 Series and 7500 Series cleared by the FDA?
Belmont Unit, Model 6000 Series and 7500 Series (K983661) received a 510(k) decision of Substantially Equivalent on January 12, 1999, 85 days after the submission was received.
What is the product code of K983661?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.