FDA product code EBF: Material, Tooth Shade, Resin
EBF is the FDA product code for material, tooth shade, resin. It is a Class II device, regulated under 21 CFR 872.3690 and reviewed by the Dental panel. FDA has cleared 936 510(k) submissions under EBF, 75 in the last five years, from 236 different applicants. The average 510(k) review took 88 days (median 69); 93 days on average over the last three years. FDA has posted 71 recalls for EBF devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Material, Tooth Shade, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3690 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 15 | 146 |
| 2018 | 15 | 137 |
| 2019 | 17 | 168 |
| 2020 | 15 | 189 |
| 2021 | 13 | 200 |
| 2022 | 17 | 122 |
| 2023 | 9 | 94 |
| 2024 | 18 | 171 |
| 2025 | 15 | 53 |
| 2026 | 16 | 54 |
Compare with all 510(k) review times · Search every EBF clearance
Top EBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Voco GmbH | 45 | 2026-04-27 |
| Bisco, Inc. | 30 | 2024-12-17 |
| Scientific Pharmaceuticals, Inc. | 29 | 1994-02-22 |
| Dentsply Intl. | 28 | 2005-04-22 |
| Ivoclar North America, Inc. | 28 | 2001-07-05 |
231 more applicants have EBF clearances. See the full list in Caduvo.
Most recent EBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262202 | GC America, Inc. | Cerasmart Forte | 2026-09-10 | 73 |
| K261695 | Guilin Kevin Peter Technology Co., Ltd. | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | 2026-08-31 | 101 |
| K261485 | Ivoclar Vivadent, Inc. | Tetric plus Fill;Tetric plus Flow | 2026-07-01 | 57 |
| K262228 | Ultradent Products, Inc. | Transcend Bulk Fill Flowable Composite | 2026-07-01 | 1 |
| K261246 | GC America, Inc. | SRGC-06 | 2026-06-18 | 63 |
Recalls for EBF devices
71 product recalls in 16 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-07-09.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2024 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code EBF?
EBF is the FDA product code for material, tooth shade, resin. It is a Class II device, regulated under 21 CFR 872.3690 and reviewed by the Dental panel.
What device class is EBF?
Class II, regulation 21 CFR 872.3690. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBF?
Across 936 cleared submissions the average was 88 days from receipt to decision (median 69).
Which companies have the most EBF clearances?
Voco GmbH (45); Bisco, Inc. (30); Scientific Pharmaceuticals, Inc. (29); Dentsply Intl. (28); Ivoclar North America, Inc. (28).
Have EBF devices been recalled?
Yes: 71 product recalls across 16 recall events; the most recent began 2026-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EBF
- Run a recall and safety report across every EBF manufacturer
- Watch product code EBF 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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