Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
liner, cavity, calcium hydroxide
Product Code
EJK
Regulation Number
872.3250
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M ESPE DENTAL PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
BISCO INC
SUBSTANTIALLY EQUIVALENT
1
BISCO, INC.
SUBSTANTIALLY EQUIVALENT
1
KURARAY NORITAKE DENTAL INC.
SUBSTANTIALLY EQUIVALENT
2
MARUCHI
SUBSTANTIALLY EQUIVALENT
1
1. K201799
CleaniCal
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PARKELL, INC.
SUBSTANTIALLY EQUIVALENT
1
PREVEST DENPRO LIMITED
SUBSTANTIALLY EQUIVALENT
1
PULPDENT CORPORATION
SUBSTANTIALLY EQUIVALENT
2
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
SUBSTANTIALLY EQUIVALENT
1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH
SUBSTANTIALLY EQUIVALENT
1
SPIDENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SYBRON DENTAL SPECIALTIES
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
1
1
2018
2
2
2019
2
2
2020
1
1
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Appropriate Term/Code Not Available
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
2
2
Hypersensitivity/Allergic reaction
1
1
Pain
1
1
Swelling
1
1
Ulcer
1
1
Sore Throat
1
1
Numbness
1
1
Sensitivity of Teeth
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Axcentria Pharmaceuticals, LLC
II
Jul-16-2014
-
-