FDA product code EAX: Mirror, Mouth
EAX is the FDA product code for mirror, mouth. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under EAX, from 11 different applicants. The average 510(k) review took 77 days (median 42). FDA has posted 1 recall for EAX devices.
Classification
| Field | Value |
|---|---|
| Device name | Mirror, Mouth |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAX clearance
Top EAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Medical Group, Inc. | 2 | 1986-10-30 |
| Hines Group , Ltd. | 1 | 1995-02-16 |
| Ranir/Dcp Corp. | 1 | 1994-09-02 |
| Union Broach, Div. Moyco Industries, Inc. | 1 | 1994-05-18 |
| Dentalsafe Systems Pty., Ltd. | 1 | 1994-02-03 |
6 more applicants have EAX clearances. See the full list in Caduvo.
Most recent EAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946073 | Hines Group , Ltd. | ORALVUE DENTAL MIRROR | 1995-02-16 | 71 |
| K935906 | Ranir/Dcp Corp. | RANIR PLAX RX | 1994-09-02 | 266 |
| K941574 | Union Broach, Div. Moyco Industries, Inc. | RETRO MIRROR | 1994-05-18 | 48 |
| K935687 | Dentalsafe Systems Pty., Ltd. | NIL | 1994-02-03 | 66 |
| K863767 | The Medical Group, Inc. | GLASS MOUTH MIRRORS, REUSABLE | 1986-10-30 | 35 |
Recalls for EAX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-23.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code EAX?
EAX is the FDA product code for mirror, mouth. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EAX?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAX?
Across 12 cleared submissions the average was 77 days from receipt to decision (median 42).
Which companies have the most EAX clearances?
The Medical Group, Inc. (2); Hines Group , Ltd. (1); Ranir/Dcp Corp. (1); Union Broach, Div. Moyco Industries, Inc. (1); Dentalsafe Systems Pty., Ltd. (1).
Have EAX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code EAX
- Run a recall and safety report across every EAX manufacturer
- Watch product code EAX 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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