C&B NFH Hybrid
FDA 510(k) K232559 · Arum Dentistry Co., Ltd.
510(k) numberK232559
Submission
- Device name
- C&B NFH Hybrid
- Applicant
- Arum Dentistry Co., Ltd.
Daejeon, KR - Received
- August 23, 2023
- Decision date
- September 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was C&B NFH Hybrid cleared by the FDA?
C&B NFH Hybrid (K232559) received a 510(k) decision of Substantially Equivalent on September 11, 2024, 385 days after the submission was received.
What is the product code of K232559?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.