FDA product code EAP: Unit, X-Ray, Intraoral
EAP is the FDA product code for unit, x-ray, intraoral. It is a Class II device, regulated under 21 CFR 872.1810 and reviewed by the Radiology panel. FDA has cleared 42 510(k) submissions under EAP, from 27 different applicants. The average 510(k) review took 93 days (median 68). FDA has posted 6 recalls for EAP devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, X-Ray, Intraoral |
| Device class | Class II |
| Regulation | 21 CFR 872.1810 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EAP clearance
Top EAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Belmont Equipment Corp. | 5 | 1990-05-23 |
| Schick Technologies, Inc. | 3 | 2009-11-30 |
| Pelton & Crane Co. | 3 | 1996-03-29 |
| Trophy Radiologie | 3 | 1995-12-28 |
| Keystone X-Ray, Inc. | 3 | 1993-11-23 |
22 more applicants have EAP clearances. See the full list in Caduvo.
Most recent EAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113360 | Humanray Co,Ltd | MEDICAL IMAGE PROCESSING UNIT | 2012-02-07 | 85 |
| K102573 | Advanced Image Science, Inc. | PROVU (TM) DENTAL X-RAY SYSTEM | 2011-06-30 | 294 |
| K093453 | Schick Technologies, Inc. | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | 2009-11-30 | 25 |
| K080738 | Dentron Systems, LLC | DENTRON SENSOR | 2008-05-13 | 57 |
| K052422 | Flow X-Ray Corp. | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | 2005-09-27 | 25 |
Recalls for EAP devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-09-26.
Frequently asked questions
What is FDA product code EAP?
EAP is the FDA product code for unit, x-ray, intraoral. It is a Class II device, regulated under 21 CFR 872.1810 and reviewed by the Radiology panel.
What device class is EAP?
Class II, regulation 21 CFR 872.1810. Typical premarket route: 510(k).
How long does a 510(k) take for product code EAP?
Across 42 cleared submissions the average was 93 days from receipt to decision (median 68).
Which companies have the most EAP clearances?
Belmont Equipment Corp. (5); Schick Technologies, Inc. (3); Pelton & Crane Co. (3); Trophy Radiologie (3); Keystone X-Ray, Inc. (3).
Have EAP devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2012-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code EAP
- Run a recall and safety report across every EAP manufacturer
- Watch product code EAP 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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