FDA product code EGY: Processor, Radiographic-Film, Automatic, Dental
EGY is the FDA product code for processor, radiographic-film, automatic, dental. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel. FDA has cleared 9 510(k) submissions under EGY, from 9 different applicants. The average 510(k) review took 54 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Processor, Radiographic-Film, Automatic, Dental |
| Device class | Class II |
| Regulation | 21 CFR 892.1900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Top EGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dental X-Ray Support Systems, Inc. | 1 | 1999-09-03 |
| Smith Companies Dental Products | 1 | 1996-04-05 |
| Denoptix, Inc. | 1 | 1996-03-01 |
| Gendex Corp. | 1 | 1995-02-09 |
| Allied Photo Products Co., Inc. | 1 | 1990-05-14 |
4 more applicants have EGY clearances. See the full list in Caduvo.
Most recent EGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992896 | Dental X-Ray Support Systems, Inc. | DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) | 1999-09-03 | 7 |
| K955825 | Smith Companies Dental Products | SMITH S-100 TIME & TEMPERATURE CONTROL | 1996-04-05 | 101 |
| K955643 | Denoptix, Inc. | ALARA IMAGING SYSTEM | 1996-03-01 | 80 |
| K945682 | Gendex Corp. | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | 1995-02-09 | 80 |
| K900156 | Allied Photo Products Co., Inc. | AP201 DENTAL X-RAY FILM PROCESSOR | 1990-05-14 | 122 |
Recalls for EGY devices
openFDA lists no recalls for product code EGY.
Frequently asked questions
What is FDA product code EGY?
EGY is the FDA product code for processor, radiographic-film, automatic, dental. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel.
What device class is EGY?
Class II, regulation 21 CFR 892.1900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGY?
Across 9 cleared submissions the average was 54 days from receipt to decision (median 43).
Which companies have the most EGY clearances?
Dental X-Ray Support Systems, Inc. (1); Smith Companies Dental Products (1); Denoptix, Inc. (1); Gendex Corp. (1); Allied Photo Products Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGY
- Run a recall and safety report across every EGY manufacturer
- Watch product code EGY 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.