Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
floss, dental
Product Code
JES
Regulation Number
872.6390
Device Class
1
Premarket Reviews
Manufacturer
Decision
PROCTER & GAMBLE CO.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
84
84
2015
45
45
2016
43
43
2017
50
50
2018
52
52
2019
52
52
2020
32
32
2021
32
32
2022
8
8
2023
3
3
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
186
186
Adverse Event Without Identified Device or Use Problem
67
67
Detachment of Device or Device Component
41
41
Insufficient Information
20
20
Detachment Of Device Component
19
19
Patient-Device Incompatibility
12
12
Device Operates Differently Than Expected
7
7
Entrapment of Device
7
7
Product Quality Problem
6
6
Material Fragmentation
5
5
Physical Resistance/Sticking
5
5
Difficult to Remove
4
4
Use of Device Problem
4
4
Device Dislodged or Dislocated
4
4
Human-Device Interface Problem
4
4
Material Integrity Problem
4
4
Appropriate Term/Code Not Available
3
3
Material Separation
3
3
Sharp Edges
3
3
Sticking
2
2
Improper or Incorrect Procedure or Method
2
2
Material Frayed
2
2
Patient Device Interaction Problem
2
2
Device Markings/Labelling Problem
2
2
Battery Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Damaged by Another Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Twisted/Bent
1
1
Improper Chemical Reaction
1
1
Incorrect Device Or Component Shipped
1
1
Material Erosion
1
1
Crack
1
1
Degraded
1
1
Defective Component
1
1
Structural Problem
1
1
Failure to Select Signal
1
1
Device Slipped
1
1
Material Too Rigid or Stiff
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
148
148
No Known Impact Or Consequence To Patient
72
72
Tooth Fracture
47
47
No Code Available
36
36
Foreign Body In Patient
28
28
Swelling
12
12
No Clinical Signs, Symptoms or Conditions
11
11
Reaction
10
10
Hypersensitivity/Allergic reaction
9
9
Pain
9
9
Inflammation
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
No Information
7
7
Insufficient Information
6
6
Injury
5
5
Sensitivity of Teeth
4
4
Discomfort
3
3
Laceration(s)
3
3
Unspecified Infection
3
3
Device Embedded In Tissue or Plaque
3
3
Nausea
2
2
Irritation
2
2
Itching Sensation
2
2
Dyspnea
2
2
Complaint, Ill-Defined
2
2
Urticaria
2
2
Malaise
2
2
Numbness
2
2
Pharyngitis
1
1
Choking
1
1
Anaphylactoid
1
1
Wheal(s)
1
1
Tissue Damage
1
1
Vomiting
1
1
Radiation Underdose
1
1
Tingling
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Failure of Implant
1
1
Abscess
1
1
Anaphylactic Shock
1
1
Angina
1
1
Dysphagia/ Odynophagia
1
1
Myocardial Infarction
1
1
Rash
1
1
Local Reaction
1
1
Syncope/Fainting
1
1
Skin Burning Sensation
1
1
Skin Inflammation/ Irritation
1
1
Unspecified Tissue Injury
1
1
-
-