American Dental Products Caries-Detector Plus
FDA 510(k) K994368 · American Dental Products, Inc.
510(k) numberK994368
Submission
- Device name
- American Dental Products Caries-Detector Plus
- Applicant
- American Dental Products, Inc.
Bensenville, IL, US - Received
- December 27, 1999
- Decision date
- March 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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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| K093014 | American Dental Products Se BondeasyKLE · Traditional | 04/16/2010SE |
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| K954637 | American Dental Products Tissue Conditioner & Temporary RelinerEBI · Traditional | 12/28/1995SE |
| K954876 | American Dental Products Root Canal Sealer, Wach's FormulaEMA · Traditional | 11/15/1995SE |
| K954701 | American Dental Products Pit & Fissue Sealant Light CuringEBC · Traditional | 10/30/1995SE |
| K954408 | American Dental Products Light Activated Composite Resin Core Buildup Blue PasteeEBF · Traditional | 10/30/1995SE |
| K954407 | American Dental Products White Composite Resin Core Paste with FluorideEBF · Traditional | 10/30/1995SE |
| K954406 | American Dental Products Composite Resin Core Paste with FluorideEBF · Traditional | 10/30/1995SE |
Questions and answers
When was American Dental Products Caries-Detector Plus cleared by the FDA?
American Dental Products Caries-Detector Plus (K994368) received a 510(k) decision of Substantially Equivalent on March 14, 2000, 78 days after the submission was received.
What is the product code of K994368?
The FDA product code is LFC – Device, Caries Detection, a Class II (moderate risk) device regulated under 21 CFR 872.1740.