FDA product code EMA: Cement, Dental
EMA is the FDA product code for cement, dental. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel. FDA has cleared 508 510(k) submissions under EMA, 28 in the last five years, from 176 different applicants. The average 510(k) review took 98 days (median 76); 109 days on average over the last three years. FDA has posted 16 recalls for EMA devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cement, Dental |
| Device class | Class II |
| Regulation | 21 CFR 872.3275 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EMA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 178 |
| 2018 | 3 | 228 |
| 2019 | 7 | 148 |
| 2020 | 8 | 167 |
| 2021 | 4 | 220 |
| 2022 | 7 | 242 |
| 2023 | 2 | 30 |
| 2024 | 3 | 64 |
| 2025 | 10 | 107 |
| 2026 | 6 | 156 |
Compare with all 510(k) review times · Search every EMA clearance
Top EMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GC America, Inc. | 30 | 2026-05-18 |
| Voco GmbH | 26 | 2026-03-20 |
| Dentsply Intl. | 19 | 2004-10-18 |
| Shofu Dental Corp. | 16 | 2011-11-17 |
| 3M Company | 12 | 2017-02-06 |
171 more applicants have EMA clearances. See the full list in Caduvo.
Most recent EMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254201 | Mediclus Co., Ltd. | Any-Cem | 2026-08-13 | 227 |
| K261937 | The Belport Company Inc., DBA Gingi-Pak | PacTemp Automix NE | 2026-08-07 | 58 |
| K261166 | DiaDent Group International | DIA-CEM | 2026-07-09 | 91 |
| K254109 | GC America, Inc. | G-CEM UNIVERSAL | 2026-05-18 | 150 |
| K253337 | Inter-Med, Inc. | REGEN Bioactive Cement | 2026-04-15 | 197 |
Recalls for EMA devices
16 product recalls in 14 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-01-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code EMA?
EMA is the FDA product code for cement, dental. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel.
What device class is EMA?
Class II, regulation 21 CFR 872.3275. Typical premarket route: 510(k).
How long does a 510(k) take for product code EMA?
Across 508 cleared submissions the average was 98 days from receipt to decision (median 76).
Which companies have the most EMA clearances?
GC America, Inc. (30); Voco GmbH (26); Dentsply Intl. (19); Shofu Dental Corp. (16); 3M Company (12).
Have EMA devices been recalled?
Yes: 16 product recalls across 14 recall events; the most recent began 2024-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code EMA
- Run a recall and safety report across every EMA manufacturer
- Watch product code EMA 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times