Pro-Scope Model # PS-4000
FDA 510(k) K922942 · Pro-Den Systems, Inc.
510(k) numberK922942
Submission
- Device name
- Pro-Scope Model # PS-4000
- Applicant
- Pro-Den Systems, Inc.
Portland, OR, US - Received
- June 18, 1992
- Decision date
- September 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K954061 | Poly-Lite Model 1000EBZ · Traditional | 09/21/1995SE |
Questions and answers
When was Pro-Scope Model # PS-4000 cleared by the FDA?
Pro-Scope Model # PS-4000 (K922942) received a 510(k) decision of Substantially Equivalent on September 10, 1993, 449 days after the submission was received.
What is the product code of K922942?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.