510(k) K171174
K171174 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "PERIO-FLOW nozzle". The FDA issued a decision of Substantially Equivalent on December 18, 2017. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2017
- Date Received
- April 21, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type