FDA product code EKZ: Unit, Electrosurgical, And Accessories, Dental
EKZ is the FDA product code for unit, electrosurgical, and accessories, dental. It is a Class II device, regulated under 21 CFR 872.4920 and reviewed by the Dental panel. FDA has cleared 19 510(k) submissions under EKZ, 1 in the last five years, from 18 different applicants. The average 510(k) review took 135 days (median 98). FDA has posted 1 recall for EKZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrosurgical, And Accessories, Dental |
| Device class | Class II |
| Regulation | 21 CFR 872.4920 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EKZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 278 |
Compare with all 510(k) review times · Search every EKZ clearance
Top EKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Macan Engineering Co. | 2 | 2005-12-09 |
| J. Morita USA, Inc. | 1 | 2022-08-03 |
| Coltene/Whaledent, Inc. | 1 | 2007-10-18 |
| Medisurg , Ltd. | 1 | 2007-04-18 |
| Xo Care A/S | 1 | 2003-04-29 |
13 more applicants have EKZ clearances. See the full list in Caduvo.
Most recent EKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213477 | J. Morita USA, Inc. | Root ZX3 | 2022-08-03 | 278 |
| K071632 | Coltene/Whaledent, Inc. | PERFECT TISSUE CONTOURING SYSTEM II | 2007-10-18 | 126 |
| K063468 | Medisurg , Ltd. | THE FUGO BLADE FOR DENTISTRY | 2007-04-18 | 153 |
| K052622 | Macan Engineering Co. | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | 2005-12-09 | 77 |
| K050735 | Macan Engineering Co. | MC6A | 2005-05-23 | 63 |
Recalls for EKZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-04-05.
Frequently asked questions
What is FDA product code EKZ?
EKZ is the FDA product code for unit, electrosurgical, and accessories, dental. It is a Class II device, regulated under 21 CFR 872.4920 and reviewed by the Dental panel.
What device class is EKZ?
Class II, regulation 21 CFR 872.4920. Typical premarket route: 510(k).
How long does a 510(k) take for product code EKZ?
Across 19 cleared submissions the average was 135 days from receipt to decision (median 98).
Which companies have the most EKZ clearances?
Macan Engineering Co. (2); J. Morita USA, Inc. (1); Coltene/Whaledent, Inc. (1); Medisurg , Ltd. (1); Xo Care A/S (1).
Have EKZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-04-05.
Next steps
- Run an FDA pathway report with predicate devices for product code EKZ
- Run a recall and safety report across every EKZ manufacturer
- Watch product code EKZ 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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