FDA product code EGZ: Holder, Film, X-Ray
EGZ is the FDA product code for holder, film, x-ray. It is a Class I device, regulated under 21 CFR 872.1905 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EGZ, from 7 different applicants. The average 510(k) review took 76 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Holder, Film, X-Ray |
| Device class | Class I |
| Regulation | 21 CFR 872.1905 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EGZ clearance
Top EGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nix Co. , Ltd. | 2 | 1991-09-06 |
| Bite-A-Block | 1 | 1989-06-12 |
| Trollplast, Inc. | 1 | 1986-01-21 |
| Strong Marketing | 1 | 1985-09-05 |
| The S. S. White Co. | 1 | 1985-08-13 |
2 more applicants have EGZ clearances. See the full list in Caduvo.
Most recent EGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913160 | Nix Co. , Ltd. | ID-TAB | 1991-09-06 | 51 |
| K913168 | Nix Co. , Ltd. | SALIBAG | 1991-09-06 | 51 |
| K890355 | Bite-A-Block | DENTAL X-RAY BITE BLOCK | 1989-06-12 | 139 |
| K853451 | Trollplast, Inc. | TROLL-BITE | 1986-01-21 | 158 |
| K852170 | Strong Marketing | EZX YELLOW, BLUE OR ORANGE | 1985-09-05 | 108 |
Recalls for EGZ devices
openFDA lists no recalls for product code EGZ.
Frequently asked questions
What is FDA product code EGZ?
EGZ is the FDA product code for holder, film, x-ray. It is a Class I device, regulated under 21 CFR 872.1905 and reviewed by the Dental panel.
What device class is EGZ?
Class I, regulation 21 CFR 872.1905. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGZ?
Across 8 cleared submissions the average was 76 days from receipt to decision (median 55).
Which companies have the most EGZ clearances?
Nix Co. , Ltd. (2); Bite-A-Block (1); Trollplast, Inc. (1); Strong Marketing (1); The S. S. White Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGZ
- Run a recall and safety report across every EGZ manufacturer
- Watch product code EGZ 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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