FDA product code EBC: Sealant, Pit And Fissure, And Conditioner
EBC is the FDA product code for sealant, pit and fissure, and conditioner. It is a Class II device, regulated under 21 CFR 872.3765 and reviewed by the Dental panel. FDA has cleared 131 510(k) submissions under EBC, 4 in the last five years, from 75 different applicants. The average 510(k) review took 81 days (median 70); 173 days on average over the last three years. FDA has posted 3 recalls for EBC devices.
Classification
| Field | Value |
|---|---|
| Device name | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class II |
| Regulation | 21 CFR 872.3765 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 186 |
| 2018 | 1 | 171 |
| 2019 | 2 | 186 |
| 2023 | 2 | 78 |
| 2025 | 1 | 297 |
| 2026 | 1 | 49 |
Compare with all 510(k) review times · Search every EBC clearance
Top EBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 11 | 1999-10-22 |
| Ultradent Products, Inc. | 7 | 2011-09-23 |
| Pulpdent Corp. | 6 | 1996-11-12 |
| Voco GmbH | 5 | 2014-02-11 |
| Pulpdent Corporation | 4 | 2018-01-05 |
70 more applicants have EBC clearances. See the full list in Caduvo.
Most recent EBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260819 | Mediclus Co., Ltd. | Any-Com Seal | 2026-05-01 | 49 |
| K243254 | Parkell, Inc. | Parkell Pit and Fissure Sealant | 2025-08-08 | 297 |
| K232498 | Ultradent Product, Inc. | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | 2023-08-18 | 1 |
| K230455 | Rizhao Huge Biomaterials Company, Ltd. | Enamel Coating Resin | 2023-07-25 | 154 |
| K190998 | Apex Dental Materials, Inc. | BA Pit & Fissure Sealant | 2019-11-08 | 206 |
Recalls for EBC devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-17.
Frequently asked questions
What is FDA product code EBC?
EBC is the FDA product code for sealant, pit and fissure, and conditioner. It is a Class II device, regulated under 21 CFR 872.3765 and reviewed by the Dental panel.
What device class is EBC?
Class II, regulation 21 CFR 872.3765. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBC?
Across 131 cleared submissions the average was 81 days from receipt to decision (median 70).
Which companies have the most EBC clearances?
Dentsply Intl. (11); Ultradent Products, Inc. (7); Pulpdent Corp. (6); Voco GmbH (5); Pulpdent Corporation (4).
Have EBC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code EBC
- Run a recall and safety report across every EBC manufacturer
- Watch product code EBC 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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