EAX
12 FDA 510(k) clearances · Product code
48 daysmedian time to decision
224 days90th percentile
12clearances measured
FDA profile
- Official device name
- Mirror, Mouth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1997: 4 · 1998: 2 · 2011: 9 · 2012: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORALVUE DENTAL MIRROR (K946073) | Hines Group , Ltd. | 1995-02-16 |
| RANIR PLAX RX (K935906) | Ranir/Dcp Corp. | 1994-09-02 |
| RETRO MIRROR (K941574) | Union Broach, Div. Moyco Industries, Inc. | 1994-05-18 |
| NIL (K935687) | Dentalsafe Systems Pty., Ltd. | 1994-02-03 |
| GLASS MOUTH MIRRORS, REUSABLE (K863767) | The Medical Group, Inc. | 1986-10-30 |
| DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (K863766) | The Medical Group, Inc. | 1986-10-30 |
| FOGCUTTER DENTAL MOUTH MIRROR (K833310) | Hti, Inc. | 1984-05-07 |
| FIBERGLASS MOUTH MIRRORS (K841199) | Henry Schein, Inc. | 1984-04-25 |
| PERI MIRROR/SALIVA EJECTOR (K833429) | Dentec, Inc. | 1983-12-22 |
| ELECTRIC MOUTH MIRROR (K830777) | Almore Intl., Inc. | 1983-04-06 |
| BEACH MOUTH MIRROR (K821777) | Pacific Dental Corp. | 1982-07-06 |
| ORAVIEW BY WATER PIK (K800919) | Teledyne, Inc. | 1980-05-08 |
Track EAX automatically
Every clearance here is in the API, with alerts when new ones post.