Shortstop Disposable Prophy Angle
FDA 510(k) K955654 · Spintech, Inc.
510(k) numberK955654
Submission
- Device name
- Shortstop Disposable Prophy Angle
- Applicant
- Spintech, Inc.
York, PA, US - Received
- December 12, 1995
- Decision date
- February 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K201624 | Spin Care Disposable Protective MaskFXX · Traditional | 03/18/2021SE |
| K173224 | Spin-SwiLNH · Traditional | 02/23/2018SE |
| K023722 | Safetywand Disposable HandpieceEJI · Traditional | 09/02/2003SE |
| K010692 | The Wand Plus Computer Controlled Anesthetic Delivery SystemFMF · Traditional | 06/29/2001SE |
| K992404 | The WandFMF · Traditional | 06/06/2000SE |
| K992819 | Wand PlusEJI · Traditional | 05/11/2000SE |
| K961648 | The WandEJI · Traditional | 07/05/1996SE |
Questions and answers
When was Shortstop Disposable Prophy Angle cleared by the FDA?
Shortstop Disposable Prophy Angle (K955654) received a 510(k) decision of Substantially Equivalent on February 8, 1996, 58 days after the submission was received.
What is the product code of K955654?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.