AH Plus Endodontic Sealer
FDA 510(k) K243546 · Dentsply Sirona, Inc.
510(k) numberK243546
Submission
- Device name
- AH Plus Endodontic Sealer
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- November 15, 2024
- Decision date
- February 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was AH Plus Endodontic Sealer cleared by the FDA?
AH Plus Endodontic Sealer (K243546) received a 510(k) decision of Substantially Equivalent on February 13, 2025, 90 days after the submission was received.
What is the product code of K243546?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.