3M VitCal Liner/Base
FDA 510(k) K230270 · 3M Espe Dental Products
510(k) numberK230270
Submission
- Device name
- 3M VitCal Liner/Base
- Applicant
- 3M Espe Dental Products
Saint Paul, MN, US - Received
- January 31, 2023
- Decision date
- February 6, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K141047 | LC Calciumhydroxide LinerEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaeten | 04/14/2015SE |
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Questions and answers
When was 3M VitCal Liner/Base cleared by the FDA?
3M VitCal Liner/Base (K230270) received a 510(k) decision of Substantially Equivalent on February 6, 2023, 6 days after the submission was received.
What is the product code of K230270?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.