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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, tooth bonding, resin
Product CodeKLE
Regulation Number 872.3200
Device Class 2


Premarket Reviews
ManufacturerDecision
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE AG
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
  SUBSTANTIALLY EQUIVALENT 1
APEX DENTAL MATERIALS, INC
  SUBSTANTIALLY EQUIVALENT 1
APEX DENTAL MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 6
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDING, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DHARMA RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
DMG AMERICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
DMP LTD
  SUBSTANTIALLY EQUIVALENT 1
E DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 2
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER GMBH
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER LLC, MITSUI CHEMICALS GROUP
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
KURARAY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 6
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MYCONE DENTAL SUPPLY CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PENTRON CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 2
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROUNDING THIRD LLC
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITÄTEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SILMET LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINO-DENTEX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 260 260
2015 100 100
2016 47 47
2017 42 42
2018 31 31
2019 20 20
2020 6 6
2021 6 6
2022 7 7
2023 7 7
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 106 106
Patient-Device Incompatibility 105 105
No Apparent Adverse Event 74 74
Adverse Event Without Identified Device or Use Problem 63 63
Appropriate Term/Code Not Available 57 57
Loss of or Failure to Bond 37 37
Improper or Incorrect Procedure or Method 31 31
Failure To Adhere Or Bond 24 24
Use of Device Problem 24 24
Detachment Of Device Component 17 17
Device Operates Differently Than Expected 10 10
Labelling, Instructions for Use or Training Problem 9 9
Device Handling Problem 6 6
Unexpected Therapeutic Results 3 3
Product Quality Problem 2 2
Improper Chemical Reaction 2 2
Material Integrity Problem 2 2
Missing Value Reason 2 2
Patient Device Interaction Problem 1 1
Component Missing 1 1
Device Issue 1 1
Increased Sensitivity 1 1
Malposition of Device 1 1
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Device Emits Odor 1 1
Component Falling 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling 132 132
Hypersensitivity/Allergic reaction 114 114
No Code Available 85 85
Sensitivity of Teeth 84 84
Edema 77 77
Skin Irritation 73 73
Pain 38 38
Caustic/Chemical Burns 31 31
Burning Sensation 28 28
No Information 20 20
Reaction 17 17
Failure of Implant 10 10
Tissue Damage 9 9
Discomfort 9 9
Eye Injury 8 8
Therapeutic Response, Decreased 7 7
Complaint, Ill-Defined 7 7
Tooth Fracture 6 6
No Known Impact Or Consequence To Patient 6 6
Ulceration 6 6
Tingling 6 6
Increased Sensitivity 6 6
Local Reaction 5 5
Inflammation 5 5
Irritation 5 5
Unspecified Infection 4 4
Erythema 4 4
Tissue Breakdown 4 4
Numbness 4 4
Chemical Exposure 3 3
Skin Inflammation/ Irritation 3 3
Rash 3 3
Dyspnea 3 3
Therapeutic Response, Increased 2 2
Ulcer 2 2
Urticaria 2 2
Erosion 2 2
Burn(s) 2 2
Anaphylactic Shock 2 2
Itching Sensation 2 2
Insufficient Information 2 2
Anaphylactoid 2 2
Sleep Dysfunction 2 2
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 1 1
Eye Burn 1 1
Post Traumatic Wound Infection 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Missing Value Reason 1 1
Cough 1 1
Stomatitis 1 1
Blister 1 1
Necrosis 1 1
Feeding Problem 1 1
Herpes 1 1
Autoimmune Reaction 1 1
Bacterial Infection 1 1
Syncope 1 1
Abscess 1 1
Chemosis 1 1
Dizziness 1 1
Skin Discoloration 1 1
Respiratory Distress 1 1
Scarring 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cosmedent, Inc. II Feb-27-2018
2 Kerr Corporation III Mar-02-2012
3 Novocol, Inc. II Jul-29-2014
4 Sybron Dental Specialties II Mar-16-2010
5 Ultradent Products, Inc. II Jul-12-2022
6 Ultradent Products, Inc. II Jun-18-2012
7 Voco GmbH II Jan-06-2017
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