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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
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDING, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  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
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
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
NOBIO 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 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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINO-DENTEX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 6 6
2021 6 6
2022 7 7
2023 7 7
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 23 23
Use of Device Problem 14 14
Adverse Event Without Identified Device or Use Problem 8 8
No Apparent Adverse Event 7 7
Improper or Incorrect Procedure or Method 6 6
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Insufficient Information 1 1
Component Missing 1 1
Improper Chemical Reaction 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 23 23
Burning Sensation 11 11
Caustic/Chemical Burns 11 11
Pain 10 10
Swelling 8 8
Edema 7 7
Skin Irritation 6 6
Eye Injury 6 6
Local Reaction 5 5
Discomfort 5 5
Skin Inflammation/ Irritation 3 3
Urticaria 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Blister 1 1
Irritation 1 1
Rash 1 1
Erythema 1 1
Dyspnea 1 1
Autoimmune Reaction 1 1
Cough 1 1
Ulcer 1 1
Deformity/ Disfigurement 1 1
Sensitivity of Teeth 1 1
Tissue Breakdown 1 1
Stomatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ultradent Products, Inc. II Jul-12-2022
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