O-Tray Impression Trays
FDA 510(k) K942668 · Dentauraum, Inc.
510(k) numberK942668
Submission
- Device name
- O-Tray Impression Trays
- Applicant
- Dentauraum, Inc.
Newtown, PA, US - Received
- June 6, 1994
- Decision date
- July 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EHY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K810525 | Sr-Ivotray UniversalEHY · Traditional | J. Aderer, Inc. | 03/17/1981SE |
More from J. Aderer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952870 | Remanium: CS & G-SoftEJH · Traditional | 07/27/1995SE |
| K952867 | Remanium:Gm 700, GM 380, GM 800, GFHEJH · Traditional | 07/27/1995SE |
| K952866 | Rematitan TitaniumEJH · Traditional | 07/27/1995SE |
| K952865 | Remanium: 200,CS, 380, and CDEJH · Traditional | 07/26/1995SE |
| K952868 | Dentaurum Jacket Crown & Root PostsEBL · Traditional | 07/19/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | 02/13/1995SE |
| K942666 | Orthalgenat Impression MaterialELW · Traditional | 08/10/1994SE |
| K936151 | Extraoral HeadgearDZB · Traditional | 08/01/1994SE |
| K942665 | Orthocent: Liquid and PowderEMA · Traditional | 07/22/1994SE |
| K935856 | Dentaurum Space MaintainerDYT · Traditional | 04/28/1994SE |
Questions and answers
When was O-Tray Impression Trays cleared by the FDA?
O-Tray Impression Trays (K942668) received a 510(k) decision of Substantially Equivalent on July 22, 1994, 46 days after the submission was received.
What is the product code of K942668?
The FDA product code is EHY – Tray, Impression, Preformed, a Class I (low risk) device regulated under 21 CFR 872.6880.