FDA product code EBP: Reliner, Denture, Over The Counter
EBP is the FDA product code for reliner, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3560 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EBP, from 3 different applicants. The average 510(k) review took 86 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Reliner, Denture, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 872.3560 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBP clearance
Top EBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perma Laboratories | 1 | 2012-06-06 |
| Majestic Drug Co., Inc. | 1 | 2010-09-20 |
| Den-Mat Corp. | 1 | 1979-08-10 |
Most recent EBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121318 | Perma Laboratories | PROSOFT | 2012-06-06 | 35 |
| K101771 | Majestic Drug Co., Inc. | RELINE-IT MODEL RELINE-IT | 2010-09-20 | 88 |
| K790589 | Den-Mat Corp. | DENTURE-TIGHT | 1979-08-10 | 136 |
Recalls for EBP devices
openFDA lists no recalls for product code EBP.
Frequently asked questions
What is FDA product code EBP?
EBP is the FDA product code for reliner, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3560 and reviewed by the Dental panel.
What device class is EBP?
Class II, regulation 21 CFR 872.3560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBP?
Across 3 cleared submissions the average was 86 days from receipt to decision (median 88).
Which companies have the most EBP clearances?
Perma Laboratories (1); Majestic Drug Co., Inc. (1); Den-Mat Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EBP
- Run a recall and safety report across every EBP manufacturer
- Watch product code EBP 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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