FDA product code EAZ: Light, Operating, Dental
EAZ is the FDA product code for light, operating, dental. It is a Class I device, regulated under 21 CFR 872.4630 and reviewed by the Dental panel. FDA has cleared 23 510(k) submissions under EAZ, from 21 different applicants. The average 510(k) review took 140 days (median 92). FDA has posted 3 recalls for EAZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Light, Operating, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4630 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAZ clearance
Top EAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Addent, Inc. | 2 | 2007-11-19 |
| Trylon Corp. | 2 | 2004-11-22 |
| Mdt Corp., Inc. | 1 | 1994-01-26 |
| Pelton & Crane Co. | 1 | 1993-12-10 |
| Den-Tal-Ez Mfg Co., Inc. | 1 | 1993-11-23 |
16 more applicants have EAZ clearances. See the full list in Caduvo.
Most recent EAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072309 | Addent, Inc. | MICROLUX/BLU | 2007-11-19 | 94 |
| K041614 | Addent, Inc. | MICROLUX DL | 2005-04-04 | 293 |
| K033033 | Trylon Corp. | VIZILITE-BLUE ORAL EXAM KIT | 2004-11-22 | 423 |
| K003995 | Trylon Corp. | SPECULITE/ORALLITE | 2001-03-16 | 80 |
| K926081 | Mdt Corp., Inc. | DENTAL LIGHT | 1994-01-26 | 421 |
Recalls for EAZ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-08.
Frequently asked questions
What is FDA product code EAZ?
EAZ is the FDA product code for light, operating, dental. It is a Class I device, regulated under 21 CFR 872.4630 and reviewed by the Dental panel.
What device class is EAZ?
Class I, regulation 21 CFR 872.4630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAZ?
Across 23 cleared submissions the average was 140 days from receipt to decision (median 92).
Which companies have the most EAZ clearances?
Addent, Inc. (2); Trylon Corp. (2); Mdt Corp., Inc. (1); Pelton & Crane Co. (1); Den-Tal-Ez Mfg Co., Inc. (1).
Have EAZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-03-08.
Next steps
- Run an FDA pathway report with predicate devices for product code EAZ
- Run a recall and safety report across every EAZ manufacturer
- Watch product code EAZ 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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