FDA product code EGI: Parallelometer
EGI is the FDA product code for parallelometer. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EGI. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Parallelometer |
| 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 EGI clearance
Top EGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.D. Charles, Inc. | 1 | 1980-08-13 |
Most recent EGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801853 | C.D. Charles, Inc. | PARALLEL-A-PREP | 1980-08-13 | 9 |
Recalls for EGI devices
openFDA lists no recalls for product code EGI.
Frequently asked questions
What is FDA product code EGI?
EGI is the FDA product code for parallelometer. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EGI?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGI?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most EGI clearances?
C.D. Charles, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGI
- Run a recall and safety report across every EGI manufacturer
- Watch product code EGI 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times