Caries Detector
FDA 510(k) K012733 · Kuraray Medical, Inc.
510(k) numberK012733
Submission
- Device name
- Caries Detector
- Applicant
- Kuraray Medical, Inc.
New York, NY, US - Received
- August 14, 2001
- Decision date
- September 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K964430 | Pulpdent SnoopLFC · Traditional | Pulpdent Corp. | 01/17/1997SE |
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Questions and answers
When was Caries Detector cleared by the FDA?
Caries Detector (K012733) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 31 days after the submission was received.
What is the product code of K012733?
The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.