FDA product code EBI: Resin, Denture, Relining, Repairing, Rebasing
EBI is the FDA product code for resin, denture, relining, repairing, rebasing. It is a Class II device, regulated under 21 CFR 872.3760 and reviewed by the Dental panel. FDA has cleared 335 510(k) submissions under EBI, 49 in the last five years, from 171 different applicants. The average 510(k) review took 104 days (median 85); 83 days on average over the last three years. FDA has posted 16 recalls for EBI devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class II |
| Regulation | 21 CFR 872.3760 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 202 |
| 2018 | 5 | 167 |
| 2019 | 4 | 130 |
| 2020 | 6 | 324 |
| 2021 | 4 | 96 |
| 2022 | 11 | 153 |
| 2023 | 11 | 110 |
| 2024 | 9 | 99 |
| 2025 | 11 | 90 |
| 2026 | 7 | 61 |
Compare with all 510(k) review times · Search every EBI clearance
Top EBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 16 | 2003-09-26 |
| GC America, Inc. | 12 | 2016-03-03 |
| Heraeus Kulzer, Inc. | 11 | 2005-01-28 |
| Voco GmbH | 8 | 2022-09-21 |
| Harry J. Bosworth Co. | 8 | 1999-05-17 |
166 more applicants have EBI clearances. See the full list in Caduvo.
Most recent EBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261802 | Prismatik Dentalcraft, Inc. | Glidewell Denture Base Resin | 2026-08-27 | 87 |
| K261626 | Guangzhou Heygears IMC., Inc. | UltraPrint Flexible Denture UV | 2026-08-13 | 90 |
| K262681 | 3BFAB TEKNOLOJI A.S. | NanoCeram Resin | 2026-07-31 | 1 |
| K262300 | Formlabs Ohio, Inc. | Denture Base Resin V2 | 2026-07-08 | 1 |
| K261474 | Dentca, Inc. | DENTCA Tru Flexible | 2026-07-01 | 58 |
Recalls for EBI devices
16 product recalls in 9 recall events; 9 initiated in the last five years and 4 still open. Most recent: 2024-01-19.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 5 |
Frequently asked questions
What is FDA product code EBI?
EBI is the FDA product code for resin, denture, relining, repairing, rebasing. It is a Class II device, regulated under 21 CFR 872.3760 and reviewed by the Dental panel.
What device class is EBI?
Class II, regulation 21 CFR 872.3760. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBI?
Across 335 cleared submissions the average was 104 days from receipt to decision (median 85).
Which companies have the most EBI clearances?
Dentsply Intl. (16); GC America, Inc. (12); Heraeus Kulzer, Inc. (11); Voco GmbH (8); Harry J. Bosworth Co. (8).
Have EBI devices been recalled?
Yes: 16 product recalls across 9 recall events; the most recent began 2024-01-19.
Next steps
- Run an FDA pathway report with predicate devices for product code EBI
- Run a recall and safety report across every EBI manufacturer
- Watch product code EBI 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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