Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling
FDA 510(k) K032605 · Meta Biomed Co., Ltd.
510(k) numberK032605
Submission
- Device name
- Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling
- Applicant
- Meta Biomed Co., Ltd.
Elmhurst, NY, US - Received
- August 25, 2003
- Decision date
- October 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K202617 | Metapex PlusKIF · Traditional | 04/14/2021SE |
| K191991 | EzfilEBF · Traditional | 03/05/2020SE |
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Questions and answers
When was Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling cleared by the FDA?
Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling (K032605) received a 510(k) decision of Substantially Equivalent on October 8, 2003, 44 days after the submission was received.
What is the product code of K032605?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.