Light-Cured Zionomer Cement
FDA 510(k) K881918 · Den-Mat Corp.
510(k) numberK881918
Submission
- Device name
- Light-Cured Zionomer Cement
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- May 9, 1988
- Decision date
- July 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K862449 | Den-Mat Dentin LinkEBF · Traditional | 07/22/1986SE |
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Questions and answers
When was Light-Cured Zionomer Cement cleared by the FDA?
Light-Cured Zionomer Cement (K881918) received a 510(k) decision of Substantially Equivalent on July 15, 1988, 67 days after the submission was received.
What is the product code of K881918?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.