PERIO-FLOW nozzle
FDA 510(k) K171174 · E.M.S Electro Medical Systems S.A
510(k) numberK171174
Submission
- Device name
- PERIO-FLOW nozzle
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- April 21, 2017
- Decision date
- December 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K191124 | Swiss LithoClast TrilogyFFK · Special | 05/29/2019SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
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Questions and answers
When was PERIO-FLOW nozzle cleared by the FDA?
PERIO-FLOW nozzle (K171174) received a 510(k) decision of Substantially Equivalent on December 18, 2017, 241 days after the submission was received.
What is the product code of K171174?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.