Proroot Mta White, Proroot Mta Gray
FDA 510(k) K142178 · Dentsply International, Inc.
510(k) numberK142178
Submission
- Device name
- Proroot Mta White, Proroot Mta Gray
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- August 8, 2014
- Decision date
- February 26, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Proroot Mta White, Proroot Mta Gray cleared by the FDA?
Proroot Mta White, Proroot Mta Gray (K142178) received a 510(k) decision of Substantially Equivalent on February 26, 2015, 202 days after the submission was received.
What is the product code of K142178?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.