Conventional Plastic Dental Trays
FDA 510(k) K841491 · Buffalo Dental Mfg. Co., Inc.
510(k) numberK841491
Submission
- Device name
- Conventional Plastic Dental Trays
- Applicant
- Buffalo Dental Mfg. Co., Inc.
Mchenry, IL, US - Received
- April 10, 1984
- Decision date
- July 13, 1984
- 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 |
| 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 |
|---|---|---|
| K955573 | Optiblast Intraoral SandblasterKOJ · Traditional | 05/03/1996SE |
| K945220 | Amalgam CarrierEKI · Traditional | 01/11/1995SE |
| K941954 | Non-Fogging Dental MirrorEKJ · Traditional | 07/08/1994SE |
| K841490 | Polysulfide Custom Tray MaterialELW · Traditional | 06/27/1984SE |
| K841323 | Fuzzy TrayEHY · Traditional | 06/27/1984SE |
| K820489 | Ultrafine Tray AdhesiveELW · Traditional | 03/19/1982SE |
| K820216 | Ultra-WetELW · Traditional | 02/24/1982SE |
| K802990 | Alginate/Silicone Crown & Bridge MaterELW · Traditional | 02/02/1981SE |
| K802882 | Hydrocolloid Compatible Cream AlginateELW · Traditional | 01/28/1981SE |
| K802662 | Polycarbonate Temporary CementEMA · Traditional | 12/16/1980SE |
Questions and answers
When was Conventional Plastic Dental Trays cleared by the FDA?
Conventional Plastic Dental Trays (K841491) received a 510(k) decision of Substantially Equivalent on July 13, 1984, 94 days after the submission was received.
What is the product code of K841491?
The FDA product code is EHY – Tray, Impression, Preformed, a Class I (low risk) device regulated under 21 CFR 872.6880.