FDA product code EAQ: Detector, Ultraviolet
EAQ is the FDA product code for detector, ultraviolet. It is a Class II device, regulated under 21 CFR 872.6350 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EAQ, from 2 different applicants. The average 510(k) review took 158 days (median 158).
Classification
| Field | Value |
|---|---|
| Device name | Detector, Ultraviolet |
| Device class | Class II |
| Regulation | 21 CFR 872.6350 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EAQ clearance
Top EAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sunsor, Inc. | 1 | 1994-07-28 |
| Parker Laboratories, Inc. | 1 | 1977-04-26 |
Most recent EAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934728 | Sunsor, Inc. | SUNSOR ULTRAVIOLET METER | 1994-07-28 | 302 |
| K770685 | Parker Laboratories, Inc. | LIGHT, EXAMINING, DENTAL, ULTRA VIOLET | 1977-04-26 | 14 |
Recalls for EAQ devices
openFDA lists no recalls for product code EAQ.
Frequently asked questions
What is FDA product code EAQ?
EAQ is the FDA product code for detector, ultraviolet. It is a Class II device, regulated under 21 CFR 872.6350 and reviewed by the Dental panel.
What device class is EAQ?
Class II, regulation 21 CFR 872.6350. Typical premarket route: 510(k).
How long does a 510(k) take for product code EAQ?
Across 2 cleared submissions the average was 158 days from receipt to decision (median 158).
Which companies have the most EAQ clearances?
Sunsor, Inc. (1); Parker Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EAQ
- Run a recall and safety report across every EAQ manufacturer
- Watch product code EAQ 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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