Mirror, Mouth
FDA product code EAX · Class I (low risk) · 21 CFR 872.4565 · Dental
12510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946073 | Oralvue Dental MirrorEAX · Traditional | Hines Group , Ltd. | 02/16/1995SE |
| K935906 | Ranir Plax RXEAX · Traditional | Ranir/Dcp Corp. | 09/02/1994SE |
| K941574 | Retro MirrorEAX · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/18/1994SE |
| K935687 | NilEAX · Traditional | Dentalsafe Systems Pty., Ltd. | 02/03/1994SE |
| K863767 | Glass Mouth Mirrors, ReusableEAX · Traditional | The Medical Group, Inc. | 10/30/1986SE |
| K863766 | Disposable Mouth Mirrors, Single Use OnlyEAX · Traditional | The Medical Group, Inc. | 10/30/1986SE |
| K833310 | Fogcutter Dental Mouth MirrorEAX · Traditional | Hti, Inc. | 05/07/1984SE |
| K841199 | Fiberglass Mouth MirrorsEAX · Traditional | Henry Schein, Inc. | 04/25/1984SE |
| K833429 | Peri Mirror/Saliva EjectorEAX · Traditional | Dentec, Inc. | 12/22/1983SE |
| K830777 | Electric Mouth MirrorEAX · Traditional | Almore Intl., Inc. | 04/06/1983SE |
| K821777 | Beach Mouth MirrorEAX · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K800919 | Oraview by Water PikEAX · Traditional | Teledyne, Inc. | 05/08/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1382-2021 Class II | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PAProduct may be contaminated with Burkholderia contaminans. | Sunstar Americas, Inc. | 03/23/2021Terminated |