Impression Material, Rubber
FDA 510(k) K790592 · Wallace A. Erickson & Co.
510(k) numberK790592
Submission
- Device name
- Impression Material, Rubber
- Applicant
- Wallace A. Erickson & Co.
Mchenry, IL, US - Received
- March 26, 1979
- Decision date
- June 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| K960122 | Alpha-Dent Temporary Crown and Bridge MaterialEBG · Traditional | 02/21/1996SE |
| K955521 | Alpha-Dent Copal Cavity VarnishLBH · Traditional | 01/24/1996SE |
| K955089 | Alpha-Dent Zinc Oxide Eugenol Temporary CementEMA · Traditional | 12/13/1995SE |
| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | 08/29/1994SE |
| K942727 | Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix AdhesiveDYH · Traditional | 08/23/1994SE |
Questions and answers
When was Impression Material, Rubber cleared by the FDA?
Impression Material, Rubber (K790592) received a 510(k) decision of Substantially Equivalent on June 15, 1979, 81 days after the submission was received.
What is the product code of K790592?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.