Disposable Mouth Mirrors, Single Use Only
FDA 510(k) K863766 · The Medical Group, Inc.
510(k) numberK863766
Submission
- Device name
- Disposable Mouth Mirrors, Single Use Only
- Applicant
- The Medical Group, Inc.
Reno, NV, US - Received
- September 25, 1986
- Decision date
- October 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAX
| 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 |
| 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 |
More from Pacific Dental Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K911246 | The Mediscus Pedcare Management System-Model 2INX · Traditional | 06/06/1991SE |
| K901295 | Pulmonair 40 Patient Management SystemIOQ · Traditional | 03/30/1990SE |
| K881843 | Pediatric Hospital BedIOQ · Traditional | 10/26/1988SE |
| K881844 | Magnum 800(TM) Management SystemFNL · Traditional | 07/14/1988SE |
| K870284 | Triangular Bandage · Traditional | 02/24/1987SE |
| K870283 | 3 X 3 Sponges, Non-SterileNAB · Traditional | 02/24/1987SE |
| K870282 | 4 X 4 Sponges, Non-SterileNAB · Traditional | 02/24/1987SE |
| K870285 | Thermometer Sheathes, Sterile (Glass)FLK · Traditional | 02/12/1987SE |
| K863769 | Evacuator TipsEHZ · Traditional | 10/30/1986SE |
| K863767 | Glass Mouth Mirrors, ReusableEAX · Traditional | 10/30/1986SE |
Questions and answers
When was Disposable Mouth Mirrors, Single Use Only cleared by the FDA?
Disposable Mouth Mirrors, Single Use Only (K863766) received a 510(k) decision of Substantially Equivalent on October 30, 1986, 35 days after the submission was received.
What is the product code of K863766?
The FDA product code is EAX – Mirror, Mouth, a Class I (low risk) device regulated under 21 CFR 872.4565.