ChlorCid, ChlorCid V, ChlorCid Surf
FDA 510(k) K173163 · Ultradent Products, Inc.
510(k) numberK173163
Submission
- Device name
- ChlorCid, ChlorCid V, ChlorCid Surf
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- September 29, 2017
- Decision date
- February 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KJJ – Cleanser, Root Canal
- Device class
- Unclassified
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| K200330 | RC-Prime Root Canal Preparation CreamKJJ · Traditional | Pac-Dent, Inc. | 07/06/2020SE |
| K162311 | Straumann PrefGelKJJ · Traditional | Institut Straumann AG | 03/07/2017SE |
| K160577 | PacEndo ChlorhexidineKJJ · Traditional | Pac-Dent International, Inc. | 07/25/2016SE |
| K153528 | PacEndo EDTAKJJ · Traditional | Pac-Dent International, Inc. | 02/01/2016SE |
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Questions and answers
When was ChlorCid, ChlorCid V, ChlorCid Surf cleared by the FDA?
ChlorCid, ChlorCid V, ChlorCid Surf (K173163) received a 510(k) decision of Substantially Equivalent on February 9, 2018, 133 days after the submission was received.
What is the product code of K173163?
The FDA product code is KJJ – Cleanser, Root Canal, a Unclassified device.