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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device agent, tooth bonding, resin
Regulation Description Resin tooth bonding agent.
Product CodeKLE
Regulation Number 872.3200
Device Class 2


Premarket Reviews
ManufacturerDecision
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDING, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 4
ROUNDING THIRD LLC
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITÄTEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINO-DENTEX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 6 6
2022 7 7
2023 7 7
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 18 18
Improper or Incorrect Procedure or Method 8 8
Use of Device Problem 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Device Handling Problem 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Improper Chemical Reaction 2 2
Product Quality Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 18 18
Caustic/Chemical Burns 8 8
Pain 5 5
Burning Sensation 5 5
Skin Inflammation/ Irritation 3 3
Burn(s) 2 2
Eye Injury 2 2
Insufficient Information 2 2
Urticaria 2 2
Dyspnea 1 1
Edema 1 1
Blister 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Rash 1 1
Local Reaction 1 1
Skin Irritation 1 1
Swelling 1 1
Tissue Breakdown 1 1
Cough 1 1
Stomatitis 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Sensitivity of Teeth 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Unitek Corporation II Jan-02-2025
2 Ultradent Products, Inc. II Jul-12-2022
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