PS System
FDA 510(k) K211721 · Inter-Med, Inc.
510(k) numberK211721
Submission
- Device name
- PS System
- Applicant
- Inter-Med, Inc.
Racine, WI, US - Received
- June 4, 2021
- Decision date
- December 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NYL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162436 | EndoVac PureNYL · Traditional | Kerr Corporation | 12/21/2016SE |
| K140685 | Endo Vac Apical Negative Pressure Irigation SystemNYL · Traditional | Sybron Endo | 07/02/2014SE |
| K100606 | Vatea Endontic Irrigation SystemNYL · Traditional | Redent Nova, Ltd. | 05/28/2010SE |
| K052271 | RinsendoNYL · Traditional | Air Techniques, Inc. | 05/26/2006SE |
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Questions and answers
When was PS System cleared by the FDA?
PS System (K211721) received a 510(k) decision of Substantially Equivalent on December 2, 2021, 181 days after the submission was received.
What is the product code of K211721?
The FDA product code is NYL – Handpiece, Air-Powered, Root Canal Irrigation, a Class I (low risk) device regulated under 21 CFR 872.4200.