• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device agent, tooth bonding, resin
Product CodeKLE
Regulation Number 872.3200
Device Class 2


Premarket Reviews
ManufacturerDecision
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
APEX DENTAL MATERIALS, INC
  SUBSTANTIALLY EQUIVALENT 1
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDING, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 4
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 2
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
META BIOMED, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  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 3
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 42 42
2018 31 31
2019 20 20
2020 6 6
2021 6 6
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 43 43
Patient-Device Incompatibility 23 23
Adverse Event Without Identified Device or Use Problem 22 22
Use of Device Problem 16 16
Improper or Incorrect Procedure or Method 10 10
Device Handling Problem 6 6
Improper Chemical Reaction 1 1
Component Missing 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling 47 47
Edema 46 46
Skin Irritation 43 43
Caustic/Chemical Burns 21 21
Hypersensitivity/Allergic reaction 19 19
Burning Sensation 15 15
Pain 9 9
Eye Injury 6 6
Discomfort 6 6
Local Reaction 5 5
Tooth Fracture 4 4
Skin Inflammation/ Irritation 3 3
Tissue Damage 3 3
Dyspnea 2 2
Rash 2 2
Sensitivity of Teeth 2 2
Complaint, Ill-Defined 2 2
Urticaria 2 2
Tingling 1 1
Ulcer 1 1
Numbness 1 1
Eye Burn 1 1
Insufficient Information 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Cough 1 1
Stomatitis 1 1
Blister 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Unspecified Infection 1 1
Irritation 1 1
Necrosis 1 1
Erythema 1 1
Syncope 1 1
Autoimmune Reaction 1 1
Chemosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cosmedent, Inc. II Feb-27-2018
2 Ultradent Products, Inc. II Jul-12-2022
3 Voco GmbH II Jan-06-2017
-
-