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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, dental
Product CodeEMA
Regulation Number 872.3275
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
3M ESPE AG
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE AG DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 3
CROWN DELTA CORP.
  SUBSTANTIALLY EQUIVALENT 1
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DENALI R&D CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DETAX GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
DFL INDUSTRIA E COMERCIO S.A.
  SUBSTANTIALLY EQUIVALENT 2
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
DMG USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DOXA AB
  SUBSTANTIALLY EQUIVALENT 1
DOXA DENTAL AB
  SUBSTANTIALLY EQUIVALENT 2
ESSENTIAL DENTAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
ESSENTIAL DENTAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTA DENTAL DIRECT, INC
  SUBSTANTIALLY EQUIVALENT 1
GAIA DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 5
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
HARRY J. BOSWORTH CO.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 2
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 4
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KURARAY MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 3
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
META BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL COMPANY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRIME DENTAL MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
S & C POLYMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHOFU DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SILMET LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STEINER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
TEMREX CORP.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS INC. / ORATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2014 207 207
2015 85 85
2016 16 16
2017 13 13
2018 4 4
2019 12 12
2020 5 5
2021 8 8
2022 3 3
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 86 86
Appropriate Term/Code Not Available 67 67
Failure To Adhere Or Bond 50 50
Patient-Device Incompatibility 48 48
Adverse Event Without Identified Device or Use Problem 34 34
Insufficient Information 19 19
Device Operates Differently Than Expected 18 18
Material Discolored 16 16
Osseointegration Problem 7 7
Increased Sensitivity 6 6
Detachment Of Device Component 6 6
Leak/Splash 5 5
Material Integrity Problem 5 5
Unexpected Color 4 4
Failure to Disconnect 3 3
Component Falling 3 3
Device Dislodged or Dislocated 2 2
Difficult to Remove 2 2
Compatibility Problem 2 2
Device Or Device Fragments Location Unknown 1 1
Output Problem 1 1
Missing Value Reason 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Component Missing 1 1
Improper Chemical Reaction 1 1
Contamination 1 1
Product Quality Problem 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 155 155
No Information 50 50
Hypersensitivity/Allergic reaction 29 29
Failure of Implant 29 29
Sensitivity of Teeth 21 21
No Known Impact Or Consequence To Patient 18 18
Pain 13 13
Swelling 12 12
Reaction 12 12
Complaint, Ill-Defined 9 9
Insufficient Information 8 8
Patient Problem/Medical Problem 7 7
Tissue Damage 5 5
Increased Sensitivity 4 4
Inflammation 4 4
Dyspnea 4 4
Anaphylactic Shock 3 3
Unspecified Infection 3 3
Rash 3 3
Itching Sensation 3 3
Burning Sensation 3 3
Skin Irritation 3 3
Tooth Fracture 3 3
Tissue Breakdown 2 2
Numbness 2 2
Missing Value Reason 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Skin Discoloration 2 2
Irritation 2 2
High Blood Pressure/ Hypertension 1 1
Syncope 1 1
Abscess 1 1
Erosion 1 1
Burn(s) 1 1
Chest Pain 1 1
Erythema 1 1
Extreme Exhaustion 1 1
Fatigue 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Occlusion 1 1
Peeling 1 1
Dizziness 1 1
Dysphasia 1 1
Anaphylactoid 1 1
Therapeutic Response, Increased 1 1
Osteolysis 1 1
Swollen Lymph Nodes 1 1
Localized Skin Lesion 1 1
Loss of consciousness 1 1
Post Traumatic Wound Infection 1 1
Shaking/Tremors 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Nov-07-2023
2 Family Dollar Stores, Llc. II Aug-17-2022
3 Henry Schein, Inc. II Jan-11-2012
4 Kerr Corp III Oct-23-2009
5 Kerr Corporation II Mar-14-2012
6 Kerr Corporation II Feb-24-2012
7 Kerr Corporation II Jan-11-2012
8 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Apr-29-2020
9 Kerr/pentron Dba Kerr Corporation And Pentron Clinical II Jan-11-2012
10 Kerr/pentron Dba Kerr Corporation And Pentron Clinical II Nov-14-2011
11 Preat Corp III Mar-06-2023
12 Voco GmbH II Feb-16-2024
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