AIR-FLOW PLUS Prophylaxis powder
FDA 510(k) K171189 · E.M.S Electro Medical Systems S.A
510(k) numberK171189
Submission
- Device name
- AIR-FLOW PLUS Prophylaxis powder
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- April 24, 2017
- Decision date
- September 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EJR
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|---|---|---|---|
| K131760 | Whip Mix Preppies PlusEJR · Traditional | Whip-Mix Corp. | 03/26/2014SE |
| K121698 | Nupro Sensodyne Prophylaxis Paste with NovaminEJR · Traditional | Dentsply International, Inc. | 08/06/2012SE |
| K103114 | Osspray Sylc CREJR · Traditional | Osspray, Ltd. | 03/14/2011SE |
| K102053 | Butler Calci-Flor Prophylaxis PasteEJR · Traditional | Sunstar Americas, Inc. | 02/03/2011SE |
| K101104 | Remin ProEJR · Traditional | Voco GmbH | 10/21/2010SE |
| K100539 | Preventech Prophylaxis Paste with FluorideEJR · Traditional | Preventive Technologies, Inc. | 06/17/2010SE |
| K070854 | GC Mi Paste PlusEJR · Special | GC America, Inc. | 04/12/2007SE |
| K062502 | Osspray Cleaning CompoundEJR · Traditional | Ospray, Ltd. | 12/15/2006SE |
| K062166 | Enamel ProEJR · Traditional | Premier Dental Products Co. | 11/21/2006SE |
| K042048 | Gelato Prophylaxis PasteEJR · Traditional | Deepak Products, Inc. | 10/26/2004SE |
More from Deepak Products, Inc.
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| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | 01/28/2026SE |
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| K230893 | Swiss LthoClast TrilogyFEO · Traditional | 10/23/2023SE |
| K220538 | DolorClast RadialISA · Traditional | 07/11/2022SE |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneELC · Traditional | 10/20/2019SE |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LEDELC · Traditional | 08/16/2019SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | 05/29/2019SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | 08/30/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | 06/20/2018SE |
Questions and answers
When was AIR-FLOW PLUS Prophylaxis powder cleared by the FDA?
AIR-FLOW PLUS Prophylaxis powder (K171189) received a 510(k) decision of Substantially Equivalent on September 11, 2017, 140 days after the submission was received.
What is the product code of K171189?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.