FDA product code EBD: Coating, Filling Material, Resin
EBD is the FDA product code for coating, filling material, resin. It is a Class II device, regulated under 21 CFR 872.3310 and reviewed by the Dental panel. FDA has cleared 52 510(k) submissions under EBD, 4 in the last five years, from 36 different applicants. The average 510(k) review took 87 days (median 62); 152 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Coating, Filling Material, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3310 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 240 |
| 2018 | 1 | 584 |
| 2021 | 1 | 159 |
| 2023 | 1 | 144 |
| 2024 | 1 | 269 |
| 2025 | 1 | 79 |
| 2026 | 1 | 108 |
Compare with all 510(k) review times · Search every EBD clearance
Top EBD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bisco, Inc. | 6 | 2005-08-22 |
| Scientific Pharmaceuticals, Inc. | 4 | 1985-03-25 |
| Cosmedent, Inc. | 3 | 2002-02-14 |
| 3M Company | 3 | 1986-07-22 |
| GC America, Inc. | 2 | 2014-03-06 |
31 more applicants have EBD clearances. See the full list in Caduvo.
Most recent EBD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254091 | YAMAHACHI DENTAL MFG., Co. | GLOSSY COAT (15ML) | 2026-04-06 | 108 |
| K250804 | Id Korea Co., Ltd. | ID LIGHT CURE SYSTEM | 2025-06-04 | 79 |
| K240735 | Bredent GmbH & Co. KG | visio.lign color, visio.lign shield | 2024-12-12 | 269 |
| K223365 | Belport Company, Inc., Gingi-Pak | RODIN Palette Naturalizing Kit | 2023-03-27 | 144 |
| K211854 | Vita Zahnfabrik GmbH H Rauter & CO | VITA Akzent LC | 2021-11-22 | 159 |
Recalls for EBD devices
openFDA lists no recalls for product code EBD.
Frequently asked questions
What is FDA product code EBD?
EBD is the FDA product code for coating, filling material, resin. It is a Class II device, regulated under 21 CFR 872.3310 and reviewed by the Dental panel.
What device class is EBD?
Class II, regulation 21 CFR 872.3310. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBD?
Across 52 cleared submissions the average was 87 days from receipt to decision (median 62).
Which companies have the most EBD clearances?
Bisco, Inc. (6); Scientific Pharmaceuticals, Inc. (4); Cosmedent, Inc. (3); 3M Company (3); GC America, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EBD
- Run a recall and safety report across every EBD manufacturer
- Watch product code EBD 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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