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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device liner, cavity, calcium hydroxide
Product CodeEJK
Regulation Number 872.3250
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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
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