Team Caries Indicator
FDA 510(k) K963927 · Centrix, Inc.
510(k) numberK963927
Submission
- Device name
- Team Caries Indicator
- Applicant
- Centrix, Inc.
Shelton, CT, US - Received
- September 10, 1996
- Decision date
- November 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code LFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222560 | BlueCheck Caries Detection & MonitoringLFC · Traditional | Incisive Technologies Pty, Ltd. | 05/16/2023SE |
| K200601 | LumiCare Caries Diagnostic RinseLFC · Traditional | GreenMark Biomedical, Inc. | 03/29/2021SE |
| K193447 | Vista DyesLFC · Traditional | Inter-Med/Vista Dental Products | 03/11/2020SE |
| K102821 | DiscovredLFC · Traditional | Phoenix Dental, Inc. | 03/11/2011SE |
| K060330 | See-It Caries DetectorLFC · Traditional | Ronvig Dental Mfg. A/S | 04/07/2006SE |
| K030807 | Caries IndicatorLFC · Traditional | Confi-Dental Products Co. | 06/09/2003SE |
| K012733 | Caries DetectorLFC · Traditional | Kuraray Medical, Inc. | 09/14/2001SE |
| K994368 | American Dental Products Caries-Detector PlusLFC · Traditional | American Dental Products, Inc. | 03/14/2000SE |
| K982105 | Oral Potential Meter (Opm)LFC · Traditional | Pertec of Wisconsin, Inc. | 09/16/1998SE |
| K973200 | Caries StainLFC · Traditional | Parkell, Inc. | 11/06/1997SE |
More from Parkell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250714 | FluoroDose VarnishLBH · Traditional | 11/21/2025SE |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38%PHR · Traditional | 10/27/2023SE |
| K200764 | StatstixMVL · Traditional | 10/15/2020SE |
| 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 |
| K021131 | ChloraprepLBH · Traditional | 09/26/2002SE |
Questions and answers
When was Team Caries Indicator cleared by the FDA?
Team Caries Indicator (K963927) received a 510(k) decision of Substantially Equivalent on November 15, 1996, 66 days after the submission was received.
What is the product code of K963927?
The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.