Chloraprep
FDA 510(k) K021131 · Centrix, Inc.
510(k) numberK021131
Submission
- Device name
- Chloraprep
- Applicant
- Centrix, Inc.
Shelton, CT, US - Received
- April 8, 2002
- Decision date
- September 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K152826 | NoCordELW · Traditional | 05/27/2016SE |
| K140144 | Benda WedgeEJB · Traditional | 07/08/2014SE |
| K120176 | Senzzzzz AwayLBH · Traditional | 07/25/2012SE |
| K111348 | Re / Stasis (TM) Gingival Retraction PasteMVL · Traditional | 07/22/2011SE |
| K092384 | LiquicordMVL · Traditional | 11/04/2009SE |
| K091380 | CordcapMVL · Traditional | 07/30/2009SE |
| K021146 | D/Sense 1-STEPEJK · Traditional | 07/02/2002SE |
Questions and answers
When was Chloraprep cleared by the FDA?
Chloraprep (K021131) received a 510(k) decision of Substantially Equivalent on September 26, 2002, 171 days after the submission was received.
What is the product code of K021131?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.