EJK · Class II · 21 CFR 872.3250

FDA Product Code EJK: Liner, Cavity, Calcium Hydroxide

Leading manufacturers include Ultradent Products, Inc., Dentsply Intl. and Centrix, Inc..

78
Total
78
Cleared
91d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 81d avg (recent)

FDA 510(k) Cleared Liner, Cavity, Calcium Hydroxide Devices (Product Code EJK)

78 devices
1–24 of 78
Cleared Jan 13, 2026
Bright Cavity Liner
K253248
Dmp Dental Industry S.A.
Dental · 106d
Cleared Feb 06, 2023
3M™ VitCal Liner/Base
K230270
3M Espe Dental Products
Dental · 6d
Cleared May 13, 2022
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
K212475
Prevest Denpro Limited
Dental · 280d
Cleared Feb 12, 2021
CleaniCal
K201799
Maruchi
Dental · 227d
Cleared Nov 20, 2020
LC ResinCal PC
K202413
S&C Polymer Silicon- Und Composite Spezialitaten GmbH
Dental · 88d
Cleared Nov 22, 2019
Parkell Desensitizer Gel
K191103
Parkell, Inc.
Dental · 211d
Cleared Apr 05, 2018
TheraCal DC
K180344
Bisco, Inc.
Dental · 56d
Cleared Aug 04, 2015
TheraCal DC
K143292
Bisco, Inc.
Dental · 260d
Cleared Dec 08, 2006
THERACAL LC
K063237
Bisco, Inc.
Dental · 43d
Cleared Apr 17, 2006
APEXCAL
K060365
Ivoclar Vivadent, Inc.
Dental · 63d
Cleared Jan 16, 2004
BISBLOCK
K033521
Bisco, Inc.
Dental · 70d
Cleared Jul 02, 2002
D/SENSE 1-STEP
K021146
Centrix, Inc.
Dental · 84d
Cleared Oct 25, 2001
LIFE 2
K012717
Sybron Dental Specialties, Inc.
Dental · 71d
Cleared Jul 21, 2000
CALCIJECT
K001050
Centrix, Inc.
Dental · 112d
Cleared Apr 02, 1997
ULTRA-BLEND PLUS
K970113
Ultradent Products, Inc.
Dental · 79d
Cleared Mar 14, 1997
ULTRACAL XS
K970114
Ultradent Products, Inc.
Dental · 60d
Cleared Jan 22, 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191
Sybron Dental Specialties, Inc.
Dental · 93d
Cleared May 30, 1996
LIFE AND LIFE FAST SET
K961708
Sybron Dental Specialties, Inc.
Dental · 28d
Cleared Aug 24, 1995
ULTRA-BLEND
K953524
Ultradent Products, Inc.
Dental · 28d
Cleared Aug 07, 1995
LIMELIGHT
K953079
Pulpdent Corp.
Dental · 35d
Cleared Nov 30, 1994
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945
Pulpdent Corp.
Dental · 54d
Cleared Nov 29, 1994
LIFE
K944416
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Sep 19, 1994
CALCIUM HYDROXIDE PASTE
K943372
Ultradent Products, Inc.
Dental · 68d
Cleared Jan 18, 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507
Centrix, Inc.
Dental · 187d

About Product Code EJK - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code EJK since 1976, with 78 receiving FDA clearance (average review time: 91 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EJK Product Code

FDA review times for EJK submissions have been consistent, averaging 81 days recently vs 92 days historically.

EJK devices are reviewed by the Dental panel. Browse all Dental devices →