FDA product code EBE: Coating, Denture Hydrophilic, Resin
EBE is the FDA product code for coating, denture hydrophilic, resin. It is a Class II device, regulated under 21 CFR 872.3300 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EBE, from 3 different applicants. The average 510(k) review took 89 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Coating, Denture Hydrophilic, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3300 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBE clearance
Top EBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chema-Scutum, Inc. | 1 | 1983-10-27 |
| Johnson & Johnson Professionals, Inc. | 1 | 1983-03-17 |
| Richardson Merrel, Inc. | 1 | 1979-07-17 |
Most recent EBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832500 | Chema-Scutum, Inc. | CS-11 | 1983-10-27 | 92 |
| K830491 | Johnson & Johnson Professionals, Inc. | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | 1983-03-17 | 30 |
| K790339 | Richardson Merrel, Inc. | CONCEPT II | 1979-07-17 | 146 |
Recalls for EBE devices
openFDA lists no recalls for product code EBE.
Frequently asked questions
What is FDA product code EBE?
EBE is the FDA product code for coating, denture hydrophilic, resin. It is a Class II device, regulated under 21 CFR 872.3300 and reviewed by the Dental panel.
What device class is EBE?
Class II, regulation 21 CFR 872.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBE?
Across 3 cleared submissions the average was 89 days from receipt to decision (median 92).
Which companies have the most EBE clearances?
Chema-Scutum, Inc. (1); Johnson & Johnson Professionals, Inc. (1); Richardson Merrel, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EBE
- Run a recall and safety report across every EBE manufacturer
- Watch product code EBE 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