EZ Bond Universal
FDA 510(k) K230009 · Meta Biomed Co., Ltd.
510(k) numberK230009
Submission
- Device name
- EZ Bond Universal
- Applicant
- Meta Biomed Co., Ltd.
Cheongju-Si, KR - Received
- January 3, 2023
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EZ Bond Universal cleared by the FDA?
EZ Bond Universal (K230009) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 59 days after the submission was received.
What is the product code of K230009?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.