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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
heat source for bleaching teeth
Product Code
EEG
Regulation Number
872.6475
Device Class
1
Premarket Reviews
Manufacturer
Decision
DR. FRESH, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNERON BEAUTY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
1
1
2016
8
8
2017
10
10
2018
6
6
2019
3
3
2020
6
6
2021
6
6
2022
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
30
30
Improper or Incorrect Procedure or Method
7
7
Patient-Device Incompatibility
6
6
Insufficient Information
3
3
Patient Device Interaction Problem
2
2
Unintended Electrical Shock
2
2
Appropriate Term/Code Not Available
1
1
Improper Chemical Reaction
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Smoking
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Sensitivity of Teeth
12
12
Reaction
7
7
Patient Problem/Medical Problem
7
7
Swelling
7
7
Pain
6
6
Burn(s)
5
5
No Clinical Signs, Symptoms or Conditions
3
3
Tooth Fracture
3
3
Burning Sensation
3
3
Hypersensitivity/Allergic reaction
2
2
Caustic/Chemical Burns
2
2
No Code Available
1
1
Dysphasia
1
1
Vaso-Vagal Response
1
1
Partial thickness (Second Degree) Burn
1
1
Swelling/ Edema
1
1
Discomfort
1
1
Arrhythmia
1
1
Unspecified Respiratory Problem
1
1
Nausea
1
1
Complaint, Ill-Defined
1
1
Red Eye(s)
1
1
Erythema
1
1
Tissue Damage
1
1
Burn, Thermal
1
1
Electric Shock
1
1
Increased Sensitivity
1
1
Full thickness (Third Degree) Burn
1
1
Ulcer
1
1
Blister
1
1
Numbness
1
1
Vomiting
1
1
Sleep Dysfunction
1
1
Headache
1
1
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