FDA product code EGS: Handpiece, Contra- And Right-Angle Attachment, Dental
EGS is the FDA product code for handpiece, contra- and right-angle attachment, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 73 510(k) submissions under EGS, 8 in the last five years, from 52 different applicants. The average 510(k) review took 153 days (median 91); 246 days on average over the last three years. FDA has posted 2 recalls for EGS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EGS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 212 |
| 2018 | 1 | 234 |
| 2019 | 3 | 284 |
| 2020 | 1 | 27 |
| 2021 | 1 | 85 |
| 2022 | 4 | 185 |
| 2023 | 1 | 131 |
| 2024 | 1 | 240 |
| 2025 | 2 | 252 |
Compare with all 510(k) review times · Search every EGS clearance
Top EGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nakanishi, Inc. | 5 | 2023-05-24 |
| Saeshin Precision Co., Ltd. | 5 | 2019-11-26 |
| Micro-Mega Societe Anonyme | 4 | 2004-11-10 |
| Handpiece Headquarters | 2 | 2014-10-23 |
| Angstrom Mfg., Inc. | 2 | 2011-02-07 |
47 more applicants have EGS clearances. See the full list in Caduvo.
Most recent EGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251869 | Premium Plus (Dongguan) Limited | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | 2025-09-15 | 89 |
| K240950 | Pacific Care Limited | Disposable Prophy Angle | 2025-05-28 | 415 |
| K240183 | Dentalez, Inc., Stardental Division | Star E900 Handpiece Series | 2024-09-19 | 240 |
| K230106 | Nakanishi, Inc. | General Cutting Straight | 2023-05-24 | 131 |
| K222518 | Nakanishi, Inc. | FX Contra | 2022-11-17 | 90 |
Recalls for EGS devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code EGS?
EGS is the FDA product code for handpiece, contra- and right-angle attachment, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EGS?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EGS?
Across 73 cleared submissions the average was 153 days from receipt to decision (median 91).
Which companies have the most EGS clearances?
Nakanishi, Inc. (5); Saeshin Precision Co., Ltd. (5); Micro-Mega Societe Anonyme (4); Handpiece Headquarters (2); Angstrom Mfg., Inc. (2).
Have EGS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code EGS
- Run a recall and safety report across every EGS manufacturer
- Watch product code EGS 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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