Ah Plus Root Canal Sealer
FDA 510(k) K960548 · Dentsply Intl.
510(k) numberK960548
Submission
- Device name
- Ah Plus Root Canal Sealer
- Applicant
- Dentsply Intl.
York, PA, US - Received
- February 8, 1996
- Decision date
- April 26, 1996
- 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 Root Canal Sealer cleared by the FDA?
Ah Plus Root Canal Sealer (K960548) received a 510(k) decision of Substantially Equivalent on April 26, 1996, 78 days after the submission was received.
What is the product code of K960548?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.