Impression Tray
FDA 510(k) K780678 · Rocky Mountain Orthodontics, Inc.
510(k) numberK780678
Submission
- Device name
- Impression Tray
- Applicant
- Rocky Mountain Orthodontics, Inc.
Mchenry, IL, US - Received
- April 24, 1978
- Decision date
- April 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EHY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942668 | O-Tray Impression TraysEHY · Traditional | Dentauraum, Inc. | 07/22/1994SE |
| K896470 | Eos Impression TraysEHY · Traditional | Ivoclar North America, Inc. | 02/09/1990SE |
| K884316 | Occlusal Harmony Impression TrayEHY · Traditional | Advantage Dental Co. | 12/22/1988SE |
| K863836 | Post TrayEHY · Traditional | Market Masters, Inc. | 10/14/1986SE |
| K850776 | Preformed Dental Impression TraysEHY · Traditional | L.A.K. Ent., Inc. | 03/18/1985SE |
| K842274 | F-G-P TrayEHY · Traditional | Di-Equi Dental Products | 07/31/1984SE |
| K842273 | Crown Index TrayEHY · Traditional | Di-Equi Dental Products | 07/31/1984SE |
| K841491 | Conventional Plastic Dental TraysEHY · Traditional | Buffalo Dental Mfg. Co., Inc. | 07/13/1984SE |
| K841323 | Fuzzy TrayEHY · Traditional | Buffalo Dental Mfg. Co., Inc. | 06/27/1984SE |
| K833485 | Impression Tube AdjustableEHY · Traditional | Zefr, Inc. | 12/26/1983SE |
More from Zefr, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895401 | Northernlights Orthodontic Bonding SystemEBF · Traditional | 12/04/1989SE |
| K843527 | Orthomite 111 AdhesiveDYH · Traditional | 10/18/1984SE |
| K780334 | Adhesive, Bracket and Conditioner ResinDYH · Traditional | 03/28/1978SE |
| K780170 | Orthodontic Bracket PadsEJF · Traditional | 03/15/1978SE |
| K780205 | Orthodontic Buccal TubeDZD · Traditional | 02/16/1978SE |
Questions and answers
When was Impression Tray cleared by the FDA?
Impression Tray (K780678) received a 510(k) decision of Substantially Equivalent on April 28, 1978, 4 days after the submission was received.
What is the product code of K780678?
The FDA product code is EHY – Tray, Impression, Preformed, a Class I (low risk) device regulated under 21 CFR 872.6880.