Non-Eugenol Temporary Cement
FDA 510(k) K020158 · J. Morita USA, Inc.
510(k) numberK020158
Submission
- Device name
- Non-Eugenol Temporary Cement
- Applicant
- J. Morita USA, Inc.
Washington, DC, US - Received
- January 17, 2002
- Decision date
- March 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Non-Eugenol Temporary Cement cleared by the FDA?
Non-Eugenol Temporary Cement (K020158) received a 510(k) decision of Substantially Equivalent on March 7, 2002, 49 days after the submission was received.
What is the product code of K020158?
The FDA product code is EMB – Zinc Oxide Eugenol, a Class I (low risk) device regulated under 21 CFR 872.3275.