FDA product code JEP: Retainer, Matrix
JEP is the FDA product code for retainer, matrix. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under JEP, from 3 different applicants. The average 510(k) review took 133 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Retainer, Matrix |
| 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 JEP clearance
Top JEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Garrison Dental Solutions | 1 | 2009-08-17 |
| Innovative Technology , Ltd. | 1 | 1993-09-23 |
| Almore Intl., Inc. | 1 | 1983-06-08 |
Most recent JEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091533 | Garrison Dental Solutions | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 | 2009-08-17 | 83 |
| K930151 | Innovative Technology , Ltd. | OMNI-MATRIX | 1993-09-23 | 254 |
| K831136 | Almore Intl., Inc. | DOUBLE BOW TOOTH SEPARATOR | 1983-06-08 | 62 |
Recalls for JEP devices
openFDA lists no recalls for product code JEP.
Frequently asked questions
What is FDA product code JEP?
JEP is the FDA product code for retainer, matrix. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is JEP?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEP?
Across 3 cleared submissions the average was 133 days from receipt to decision (median 83).
Which companies have the most JEP clearances?
Garrison Dental Solutions (1); Innovative Technology , Ltd. (1); Almore Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEP
- Run a recall and safety report across every JEP manufacturer
- Watch product code JEP 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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