FDA product code LBH: Varnish, Cavity
LBH is the FDA product code for varnish, cavity. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel. FDA has cleared 139 510(k) submissions under LBH, 16 in the last five years, from 80 different applicants. The average 510(k) review took 127 days (median 88); 195 days on average over the last three years. FDA has posted 9 recalls for LBH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Varnish, Cavity |
| Device class | Class II |
| Regulation | 21 CFR 872.3260 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 360 |
| 2020 | 5 | 236 |
| 2022 | 1 | 2 |
| 2023 | 3 | 138 |
| 2024 | 3 | 241 |
| 2025 | 4 | 218 |
| 2026 | 5 | 127 |
Compare with all 510(k) review times · Search every LBH clearance
Top LBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultradent Products, Inc. | 9 | 2026-04-30 |
| Scientific Pharmaceuticals, Inc. | 8 | 1999-02-12 |
| Pulpdent Corp. | 7 | 2001-12-12 |
| Novamin Technology, Inc. | 6 | 2008-03-27 |
| Centrix, Inc. | 5 | 2025-11-21 |
75 more applicants have LBH clearances. See the full list in Caduvo.
Most recent LBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262243 | Kettenbach GmbH & Co. KG | Profisil Free | 2026-09-03 | 64 |
| K253052 | Nagy Oral Technology Qinhuangdao Co., Ltd. | Fluoride Varnish (Type A,Type C) | 2026-06-11 | 262 |
| K252073 | Voco GmbH | VOCO Profluorid Varnish + BioMin | 2026-05-01 | 303 |
| K261404 | Ultradent Products, Inc. | UltraEZ | 2026-04-30 | 1 |
| K260830 | Sangi Co., Ltd. | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | 2026-03-18 | 5 |
Recalls for LBH devices
9 product recalls in 8 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-07-21.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LBH?
LBH is the FDA product code for varnish, cavity. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel.
What device class is LBH?
Class II, regulation 21 CFR 872.3260. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBH?
Across 139 cleared submissions the average was 127 days from receipt to decision (median 88).
Which companies have the most LBH clearances?
Ultradent Products, Inc. (9); Scientific Pharmaceuticals, Inc. (8); Pulpdent Corp. (7); Novamin Technology, Inc. (6); Centrix, Inc. (5).
Have LBH devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2023-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LBH
- Run a recall and safety report across every LBH manufacturer
- Watch product code LBH 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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