Ranir Plax RX
FDA 510(k) K935906 · Ranir/Dcp Corp.
510(k) numberK935906
Submission
- Device name
- Ranir Plax RX
- Applicant
- Ranir/Dcp Corp.
Grand Rapids, MI, US - Received
- December 10, 1993
- Decision date
- September 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946073 | Oralvue Dental MirrorEAX · Traditional | Hines Group , Ltd. | 02/16/1995SE |
| 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 |
More from Pacific Dental Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955530 | Ranir Hi-Technology Dental FlossEFW · Traditional | 12/28/1995SE |
| K942690 | Ranir Dental Tape Mint Waxed with FluorideJES · Traditional | 04/27/1995SE |
| K942689 | Ranir Dental Floss Mint Waxed with FluorideJES · Traditional | 04/27/1995SE |
| K935522 | Ranir Dental Tape Mint Waxed with FlourideJES · Traditional | 01/26/1994SE |
| K924739 | The Dentist's Tooth PolisherJEQ · Traditional | 11/24/1992SE |
Questions and answers
When was Ranir Plax RX cleared by the FDA?
Ranir Plax RX (K935906) received a 510(k) decision of Substantially Equivalent on September 2, 1994, 266 days after the submission was received.
What is the product code of K935906?
The FDA product code is EAX – Mirror, Mouth, a Class I (low risk) device regulated under 21 CFR 872.4565.