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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 resin, denture, relining, repairing, rebasing
Regulation Description Denture relining, repairing, or rebasing resin.
Product CodeEBI
Regulation Number 872.3760
Device Class 2


Premarket Reviews
ManufacturerDecision
CMP INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K153253  GC Reline II
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 1
JUVORA
  SUBSTANTIALLY EQUIVALENT 1
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
  SUBSTANTIALLY EQUIVALENT 1
PROTECH PROFESSIONAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE MYERSON COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
THERMOPLASTIC COMFORT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 8 8
2016 9 9
2017 2 2
2018 2 2
2019 10 10
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Patient-Device Incompatibility 13 13
Use of Device Problem 4 4
Insufficient Information 3 3
Device Handling Problem 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1
Gas Output Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 13 14
Reaction 10 10
Complaint, Ill-Defined 6 6
Burning Sensation 6 6
Swelling 6 6
Inflammation 5 5
Rash 3 3
Erythema 2 2
High Blood Pressure/ Hypertension 2 2
Pain 2 2
Local Reaction 1 1
Tachycardia 1 1
Discomfort 1 1
Anaphylactic Shock 1 1
Eye Injury 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Nausea 1 1
Injury 1 1
Chest Tightness/Pressure 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
No Code Available 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Irritation 1 1
Swollen Lymph Nodes 1 1
Ulceration 1 1
Sensitivity of Teeth 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CMP Industries, Llc II Oct-30-2018
2 CMP Industries, Llc II Jun-29-2016
3 CMP Industries, Llc II Jun-29-2016
4 CMP Industries, Llc II Mar-09-2016
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