Bright MTA Sealer Plus
FDA 510(k) K231480 · Genoss Co., Ltd.
510(k) numberK231480
Submission
- Device name
- Bright MTA Sealer Plus
- Applicant
- Genoss Co., Ltd.
Suwon-Si, KR - Received
- May 22, 2023
- Decision date
- July 28, 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 Bright MTA Sealer Plus cleared by the FDA?
Bright MTA Sealer Plus (K231480) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 67 days after the submission was received.
What is the product code of K231480?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.