FDA product code EBG: Crown And Bridge, Temporary, Resin
EBG is the FDA product code for crown and bridge, temporary, resin. It is a Class II device, regulated under 21 CFR 872.3770 and reviewed by the Dental panel. FDA has cleared 189 510(k) submissions under EBG, 16 in the last five years, from 133 different applicants. The average 510(k) review took 118 days (median 86); 127 days on average over the last three years. FDA has posted 4 recalls for EBG devices.
Classification
| Field | Value |
|---|---|
| Device name | Crown And Bridge, Temporary, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 134 |
| 2018 | 4 | 200 |
| 2019 | 6 | 115 |
| 2020 | 14 | 231 |
| 2021 | 3 | 210 |
| 2022 | 3 | 314 |
| 2023 | 2 | 120 |
| 2024 | 5 | 191 |
| 2025 | 4 | 114 |
| 2026 | 2 | 77 |
Compare with all 510(k) review times · Search every EBG clearance
Top EBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GC America, Inc. | 6 | 2020-07-09 |
| Ivoclar Vivadent, Inc. | 6 | 2016-04-12 |
| Sybron Dental Specialties, Inc. | 6 | 2003-07-02 |
| Voco GmbH | 5 | 2020-09-09 |
| Dmg USA, Inc. | 5 | 2010-09-28 |
128 more applicants have EBG clearances. See the full list in Caduvo.
Most recent EBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261261 | Hangzhou SHINING3D Dental Technology Co., Ltd. | Dura-Arch | 2026-04-17 | 1 |
| K253380 | Liaoning Upcera Co., Ltd. | FLNT Base and FLNT Temp | 2026-03-02 | 153 |
| K251271 | Rizhao Huge Biomaterials Company, Ltd. | TempFIT Temporary Crown and Bridge Resin | 2025-06-23 | 60 |
| K243370 | Asiga Pty, Ltd. | DentaTOOTH | 2025-05-05 | 187 |
| K243621 | Evoden Indústria Comércio Importação E Exportação | Evoblock, Perléon | 2025-04-22 | 151 |
Recalls for EBG devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-10-09.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code EBG?
EBG is the FDA product code for crown and bridge, temporary, resin. It is a Class II device, regulated under 21 CFR 872.3770 and reviewed by the Dental panel.
What device class is EBG?
Class II, regulation 21 CFR 872.3770. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBG?
Across 189 cleared submissions the average was 118 days from receipt to decision (median 86).
Which companies have the most EBG clearances?
GC America, Inc. (6); Ivoclar Vivadent, Inc. (6); Sybron Dental Specialties, Inc. (6); Voco GmbH (5); Dmg USA, Inc. (5).
Have EBG devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2020-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EBG
- Run a recall and safety report across every EBG manufacturer
- Watch product code EBG 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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