Caries Detector
FDA 510(k) K951813 · Kuraray Co.
510(k) numberK951813
Submission
- Device name
- Caries Detector
- Applicant
- Kuraray Co.
Washington, DC, US - Received
- April 18, 1995
- Decision date
- July 11, 1995
- 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 |
|---|---|---|
| K001914 | Clearfil RepairKLE · Traditional | 08/10/2000SE |
| K001913 | Clearfil ST OpaquerEBF · Traditional | 08/04/2000SE |
| K990040 | Clearfil Se BondKLE · Traditional | 02/04/1999SE |
| K980232 | Clearfil DC CementEMA · Traditional | 02/24/1998SE |
| K965091 | Teethmate F-1EBC · Traditional | 03/27/1997SE |
| K943170 | Clearfil Liner Bond 2KLE · Traditional | 08/10/1994SE |
| K943169 | Clearfil Ap-X and Liner Bond 2EBF · Traditional | 08/10/1994SE |
| K943168 | Clearfil Ap-XEBF · Traditional | 08/10/1994SE |
| K943167 | Clearfil New BondKLE · Traditional | 08/10/1994SE |
| K943166 | Clearfil Liner Bond SystemKLE · Traditional | 08/10/1994SE |
Questions and answers
When was Caries Detector cleared by the FDA?
Caries Detector (K951813) received a 510(k) decision of Substantially Equivalent on July 11, 1995, 84 days after the submission was received.
What is the product code of K951813?
The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.