Dental Cement, Zinc Phosphate
FDA 510(k) K790593 · Wallace A. Erickson & Co.
510(k) numberK790593
Submission
- Device name
- Dental Cement, Zinc Phosphate
- 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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| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
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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 |
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| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | 08/29/1994SE |
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Questions and answers
When was Dental Cement, Zinc Phosphate cleared by the FDA?
Dental Cement, Zinc Phosphate (K790593) 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 K790593?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.