Satin Cast Econocast
FDA 510(k) K833287 · Genesis Industries, Inc.
510(k) numberK833287
Submission
- Device name
- Satin Cast Econocast
- Applicant
- Genesis Industries, Inc.
Mchenry, IL, US - Received
- September 22, 1983
- Decision date
- January 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992649 | Atd Automatic Bridge RemoverEIS · Traditional | J. Morita USA, Inc. | 10/29/1999SE |
| K951299 | Easy Pneumatic Crown and Bridge RemoverEIS · Traditional | Dentco, Inc. | 08/29/1995SE |
| K863500 | Stainless Steel Den. Crown Remover & Ama./Comp.CarEIS · Traditional | Pacific Union Dental, Inc. | 09/22/1986SE |
| K854795 | Hazelton Temporary Crown and Bridge RemoverEIS · Traditional | Fran Hazelton Co. | 03/04/1986SE |
| K842026 | H-Type Bridge RemoverEIS · Traditional | Higa Manufacturing , Ltd. | 07/11/1984SE |
| K833290 | C & B 40 Pentro C & B40EIS · Traditional | Genesis Industries, Inc. | 01/03/1984SE |
| K833736 | Gold-Palladium-Silver Based Cast/AlloyEIS · Traditional | Jeneric Ind. | 12/29/1983SE |
| K833289 | C & B 61 Pentron C & B61EIS · Traditional | Genesis Industries, Inc. | 12/29/1983SE |
| K833278 | C & B 45EIS · Traditional | Genesis Industries, Inc. | 12/29/1983SE |
| K833280 | Supra Ap Choice 83EIS · Traditional | Genesis Industries, Inc. | 12/26/1983SE |
More from Genesis Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994361 | Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six…MQK · Traditional | 02/18/2000SE |
| K962828 | Evert-ItHGY · Traditional | 02/10/1997SE |
| K880377 | Novo Vivo Model #17140 and #17135GAA · Traditional | 04/04/1988SE |
| K880376 | Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional | 02/16/1988SE |
| K833290 | C & B 40 Pentro C & B40EIS · Traditional | 01/03/1984SE |
| K833289 | C & B 61 Pentron C & B61EIS · Traditional | 12/29/1983SE |
| K833278 | C & B 45EIS · Traditional | 12/29/1983SE |
| K833280 | Supra Ap Choice 83EIS · Traditional | 12/26/1983SE |
| K833285 | RX IV Pentron IVEIS · Traditional | 12/22/1983SE |
| K833288 | C & B57 Pentron C & B57EIS · Traditional | 12/20/1983SE |
Questions and answers
When was Satin Cast Econocast cleared by the FDA?
Satin Cast Econocast (K833287) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 103 days after the submission was received.
What is the product code of K833287?
The FDA product code is EIS – Remover, Crown, a Class I (low risk) device regulated under 21 CFR 872.4565.