FDA product code EAY: Light, Fiber Optic, Dental
EAY is the FDA product code for light, fiber optic, dental. It is a Class I device, regulated under 21 CFR 872.4620 and reviewed by the Dental panel. FDA has cleared 18 510(k) submissions under EAY, from 12 different applicants. The average 510(k) review took 41 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Light, Fiber Optic, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4620 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAY clearance
Top EAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midwest | 5 | 1979-11-20 |
| Beaverstate Dental, Inc. | 2 | 1995-09-05 |
| Lares Manufacturing Co., Inc. | 2 | 1980-07-21 |
| Jedental Co., Inc. | 1 | 1994-01-26 |
| Stryker Corp. | 1 | 1987-08-03 |
7 more applicants have EAY clearances. See the full list in Caduvo.
Most recent EAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953192 | Beaverstate Dental, Inc. | MODEL A15-103 | 1995-09-05 | 74 |
| K953191 | Beaverstate Dental, Inc. | MODEL A15-101 | 1995-09-05 | 74 |
| K935718 | Jedental Co., Inc. | JEDENTAL VLC DENTAL CURING LIGHT | 1994-01-26 | 57 |
| K871816 | Stryker Corp. | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | 1987-08-03 | 84 |
| K831976 | Ritter Co. | POWER OPTIC | 1983-08-12 | 53 |
Recalls for EAY devices
openFDA lists no recalls for product code EAY.
Frequently asked questions
What is FDA product code EAY?
EAY is the FDA product code for light, fiber optic, dental. It is a Class I device, regulated under 21 CFR 872.4620 and reviewed by the Dental panel.
What device class is EAY?
Class I, regulation 21 CFR 872.4620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAY?
Across 18 cleared submissions the average was 41 days from receipt to decision (median 44).
Which companies have the most EAY clearances?
Midwest (5); Beaverstate Dental, Inc. (2); Lares Manufacturing Co., Inc. (2); Jedental Co., Inc. (1); Stryker Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EAY
- Run a recall and safety report across every EAY manufacturer
- Watch product code EAY 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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