FDA product code EBZ: Activator, Ultraviolet, For Polymerization
EBZ is the FDA product code for activator, ultraviolet, for polymerization. It is a Class II device, regulated under 21 CFR 872.6070 and reviewed by the Dental panel. FDA has cleared 214 510(k) submissions under EBZ, 14 in the last five years, from 126 different applicants. The average 510(k) review took 95 days (median 65); 159 days on average over the last three years. FDA has posted 4 recalls for EBZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Activator, Ultraviolet, For Polymerization |
| Device class | Class II |
| Regulation | 21 CFR 872.6070 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 229 |
| 2018 | 2 | 138 |
| 2019 | 5 | 215 |
| 2020 | 5 | 173 |
| 2021 | 1 | 4 |
| 2022 | 5 | 141 |
| 2023 | 3 | 209 |
| 2024 | 1 | 90 |
| 2025 | 4 | 121 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every EBZ clearance
Top EBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Monitex Industrial Co., Ltd. | 9 | 2017-11-27 |
| Rolence Enterprise Co. , Ltd. | 8 | 2000-10-10 |
| Ultradent Products, Inc. | 7 | 2022-02-22 |
| Ivoclar Vivadent, Inc. | 6 | 2011-08-29 |
| Dentsply Intl. | 5 | 1995-05-05 |
121 more applicants have EBZ clearances. See the full list in Caduvo.
Most recent EBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253131 | Guangzhou Rebornendo Medical Instrument Co., Ltd. | Curing Light (M-Cure 6) | 2026-06-18 | 266 |
| K253461 | Meta Systems Co., Ltd. | Demi Pro | 2025-10-14 | 7 |
| K242386 | Genoss Co., Ltd. | Bluemoon | 2025-05-05 | 266 |
| K243921 | Foshan Coxo Medical Instrument Co., Ltd. | LED Curing Lights (DB686 HALO) | 2025-04-11 | 112 |
| K250009 | Premium Plus (Dongguan) Limited | LED Curing Light (C01-X, C02-X) | 2025-04-10 | 98 |
Recalls for EBZ devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-01-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code EBZ?
EBZ is the FDA product code for activator, ultraviolet, for polymerization. It is a Class II device, regulated under 21 CFR 872.6070 and reviewed by the Dental panel.
What device class is EBZ?
Class II, regulation 21 CFR 872.6070. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBZ?
Across 214 cleared submissions the average was 95 days from receipt to decision (median 65).
Which companies have the most EBZ clearances?
Monitex Industrial Co., Ltd. (9); Rolence Enterprise Co. , Ltd. (8); Ultradent Products, Inc. (7); Ivoclar Vivadent, Inc. (6); Dentsply Intl. (5).
Have EBZ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EBZ
- Run a recall and safety report across every EBZ manufacturer
- Watch product code EBZ 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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