FDA product code LFC: Device, Caries Detection
LFC is the FDA product code for device, caries detection. It is a Class II device, regulated under 21 CFR 872.1740 and reviewed by the Dental panel. FDA has cleared 17 510(k) submissions under LFC, 1 in the last five years, from 17 different applicants. The average 510(k) review took 107 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Device, Caries Detection |
| Device class | Class II |
| Regulation | 21 CFR 872.1740 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LFC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 89 |
| 2021 | 1 | 385 |
| 2023 | 1 | 265 |
Compare with all 510(k) review times · Search every LFC clearance
Top LFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Incisive Technologies Pty, Ltd. | 1 | 2023-05-16 |
| GreenMark Biomedical, Inc. | 1 | 2021-03-29 |
| Inter-Med/Vista Dental Products | 1 | 2020-03-11 |
| Phoenix Dental, Inc. | 1 | 2011-03-11 |
| Ronvig Dental Mfg. A/S | 1 | 2006-04-07 |
12 more applicants have LFC clearances. See the full list in Caduvo.
Most recent LFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222560 | Incisive Technologies Pty, Ltd. | BlueCheck Caries Detection & Monitoring | 2023-05-16 | 265 |
| K200601 | GreenMark Biomedical, Inc. | LumiCare Caries Diagnostic Rinse | 2021-03-29 | 385 |
| K193447 | Inter-Med/Vista Dental Products | Vista Dyes | 2020-03-11 | 89 |
| K102821 | Phoenix Dental, Inc. | DISCOVRED | 2011-03-11 | 164 |
| K060330 | Ronvig Dental Mfg. A/S | SEE-IT CARIES DETECTOR | 2006-04-07 | 57 |
Recalls for LFC devices
openFDA lists no recalls for product code LFC.
Frequently asked questions
What is FDA product code LFC?
LFC is the FDA product code for device, caries detection. It is a Class II device, regulated under 21 CFR 872.1740 and reviewed by the Dental panel.
What device class is LFC?
Class II, regulation 21 CFR 872.1740. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFC?
Across 17 cleared submissions the average was 107 days from receipt to decision (median 78).
Which companies have the most LFC clearances?
Incisive Technologies Pty, Ltd. (1); GreenMark Biomedical, Inc. (1); Inter-Med/Vista Dental Products (1); Phoenix Dental, Inc. (1); Ronvig Dental Mfg. A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFC
- Run a recall and safety report across every LFC manufacturer
- Watch product code LFC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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