FDA product code EHY: Tray, Impression, Preformed
EHY is the FDA product code for tray, impression, preformed. It is a Class I device, regulated under 21 CFR 872.6880 and reviewed by the Dental panel. FDA has cleared 16 510(k) submissions under EHY, from 13 different applicants. The average 510(k) review took 42 days (median 33). FDA has posted 3 recalls for EHY devices.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Impression, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.6880 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EHY clearance
Top EHY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Di-Equi Dental Products | 2 | 1984-07-31 |
| Buffalo Dental Mfg. Co., Inc. | 2 | 1984-07-13 |
| J. Aderer, Inc. | 2 | 1981-03-17 |
| Dentauraum, Inc. | 1 | 1994-07-22 |
| Ivoclar North America, Inc. | 1 | 1990-02-09 |
8 more applicants have EHY clearances. See the full list in Caduvo.
Most recent EHY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942668 | Dentauraum, Inc. | O-TRAY IMPRESSION TRAYS | 1994-07-22 | 46 |
| K896470 | Ivoclar North America, Inc. | EOS IMPRESSION TRAYS | 1990-02-09 | 88 |
| K884316 | Advantage Dental Co. | OCCLUSAL HARMONY IMPRESSION TRAY | 1988-12-22 | 70 |
| K863836 | Market Masters, Inc. | POST TRAY | 1986-10-14 | 14 |
| K850776 | L.A.K. Ent., Inc. | PREFORMED DENTAL IMPRESSION TRAYS | 1985-03-18 | 20 |
Recalls for EHY devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-05-19.
Frequently asked questions
What is FDA product code EHY?
EHY is the FDA product code for tray, impression, preformed. It is a Class I device, regulated under 21 CFR 872.6880 and reviewed by the Dental panel.
What device class is EHY?
Class I, regulation 21 CFR 872.6880. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHY?
Across 16 cleared submissions the average was 42 days from receipt to decision (median 33).
Which companies have the most EHY clearances?
Di-Equi Dental Products (2); Buffalo Dental Mfg. Co., Inc. (2); J. Aderer, Inc. (2); Dentauraum, Inc. (1); Ivoclar North America, Inc. (1).
Have EHY devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code EHY
- Run a recall and safety report across every EHY manufacturer
- Watch product code EHY 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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