FDA product code EBH: Material, Impression Tray, Resin
EBH is the FDA product code for material, impression tray, resin. It is a Class I device, regulated under 21 CFR 872.3670 and reviewed by the Dental panel. FDA has cleared 30 510(k) submissions under EBH, from 21 different applicants. The average 510(k) review took 71 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Material, Impression Tray, Resin |
| Device class | Class I |
| Regulation | 21 CFR 872.3670 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EBH clearance
Top EBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 5 | 1992-11-17 |
| Espe GmbH (Us) | 3 | 1988-07-27 |
| Heraeus Kulzer, Inc. | 2 | 1993-06-18 |
| Kulzer, Inc. | 2 | 1991-06-06 |
| Dentron, Inc. | 2 | 1982-06-10 |
16 more applicants have EBH clearances. See the full list in Caduvo.
Most recent EBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933745 | Bio-Systems Research | PERMAGEN UNIVERSAL BONDING RESIN | 1994-01-26 | 176 |
| K930487 | Heraeus Kulzer, Inc. | PALATRAY LC MINT | 1993-06-18 | 140 |
| K923979 | Dentsply Intl. | LC TRAY MATERIAL | 1992-11-17 | 103 |
| K923549 | Heraeus Kulzer, Inc. | PALADISC LC | 1992-09-29 | 75 |
| K912820 | E&D Dental Products, Inc. | POLYESTER RESIN HAND MOLDED TRAY | 1991-08-21 | 57 |
Recalls for EBH devices
openFDA lists no recalls for product code EBH.
Frequently asked questions
What is FDA product code EBH?
EBH is the FDA product code for material, impression tray, resin. It is a Class I device, regulated under 21 CFR 872.3670 and reviewed by the Dental panel.
What device class is EBH?
Class I, regulation 21 CFR 872.3670. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBH?
Across 30 cleared submissions the average was 71 days from receipt to decision (median 62).
Which companies have the most EBH clearances?
Dentsply Intl. (5); Espe GmbH (Us) (3); Heraeus Kulzer, Inc. (2); Kulzer, Inc. (2); Dentron, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EBH
- Run a recall and safety report across every EBH manufacturer
- Watch product code EBH 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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