Cleared Traditional

3M? VitCal Liner/Base

K230270 · 3M Espe Dental Products · Dental
Feb 2023
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K230270 is an FDA 510(k) clearance for the 3M? VitCal Liner/Base, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on February 6, 2023, 6 days after receiving the submission on January 31, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K230270 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2023
Decision Date February 06, 2023
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250