510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230270Substantially Equivalent

3M™ VitCal Liner/Base

3M ESPE Dental Products, Saint Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230270 is the FDA 510(k) clearance record for 3M™ VitCal Liner/Base, a class II device, cleared for 3M Espe Dental Products on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 12 510(k) clearances for 3M Espe Dental Products, from to . As of , FDA records show no recalls naming K230270.

Clearance record

Decision date
Received
(6 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
3M Espe Dental Products 2510 Conway Ave., Saint Paul MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EJK

Trailing 12 months
2 clearances under product code EJK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260