FDA product code EIY: Instrument, Filling, Plastic, Dental
EIY is the FDA product code for instrument, filling, plastic, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under EIY, from 4 different applicants. The average 510(k) review took 38 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Filling, Plastic, Dental |
| 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 EIY clearance
Top EIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 2 | 1987-05-27 |
| Artiberia | 1 | 1985-07-02 |
| Almore Intl., Inc. | 1 | 1983-04-28 |
| Miltex, Inc. | 1 | 1982-11-24 |
Most recent EIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871909 | Dentsply Intl. | COMPOSITE RESTORATIVE CARRIER | 1987-05-27 | 9 |
| K851726 | Artiberia | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | 1985-07-02 | 68 |
| K833955 | Dentsply Intl. | NOVEL DISPENSER/PACKAGE | 1984-01-03 | 48 |
| K830776 | Almore Intl., Inc. | MICROFIL CONTOURING INSTRUMENTS | 1983-04-28 | 48 |
| K823323 | Miltex, Inc. | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | 1982-11-24 | 16 |
Recalls for EIY devices
openFDA lists no recalls for product code EIY.
Frequently asked questions
What is FDA product code EIY?
EIY is the FDA product code for instrument, filling, plastic, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIY?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIY?
Across 5 cleared submissions the average was 38 days from receipt to decision (median 48).
Which companies have the most EIY clearances?
Dentsply Intl. (2); Artiberia (1); Almore Intl., Inc. (1); Miltex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIY
- Run a recall and safety report across every EIY manufacturer
- Watch product code EIY 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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