Remin Pro
FDA 510(k) K101104 · Voco GmbH
510(k) numberK101104
Submission
- Device name
- Remin Pro
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- April 20, 2010
- Decision date
- October 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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 |
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| K042048 | Gelato Prophylaxis PasteEJR · Traditional | Deepak Products, Inc. | 10/26/2004SE |
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Questions and answers
When was Remin Pro cleared by the FDA?
Remin Pro (K101104) received a 510(k) decision of Substantially Equivalent on October 21, 2010, 184 days after the submission was received.
What is the product code of K101104?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.