510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921408Substantially Equivalent

Light Cure Dentin and Liner Base Product Line

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921408 is the FDA 510(k) clearance record for LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE, a class II device, cleared for Ultradent Products, Inc. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K921408.

Clearance record

Decision date
Received
(245 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 S., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code EJK

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