CLEARFIL MAJESTY ES Flow
FDA 510(k) K191980 · Kuraray Noritake Dental, Inc.
510(k) numberK191980
Submission
- Device name
- CLEARFIL MAJESTY ES Flow
- Applicant
- Kuraray Noritake Dental, Inc.
Chiyoda-Ku, JP - Received
- July 24, 2019
- Decision date
- November 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was CLEARFIL MAJESTY ES Flow cleared by the FDA?
CLEARFIL MAJESTY ES Flow (K191980) received a 510(k) decision of Substantially Equivalent on November 18, 2019, 117 days after the submission was received.
What is the product code of K191980?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.