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
instruments, dental hand
Product Code
DZN
Regulation Number
872.4565
Device Class
1
Premarket Reviews
Manufacturer
Decision
KERRHAWE SA
SUBSTANTIALLY EQUIVALENT
1
1. K111465
COMPOTHIXO
MDR Year
MDR Reports
MDR Events
2014
76
76
2015
51
51
2016
30
30
2017
17
17
2018
9
9
2019
12
12
2020
15
15
2021
21
21
2022
26
26
2023
38
38
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
284
284
Peeled/Delaminated
5
5
Flaked
5
5
Material Integrity Problem
5
5
Bent
4
4
Adverse Event Without Identified Device or Use Problem
2
2
Separation Failure
2
2
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
2
2
Component Incompatible
2
2
Crack
1
1
Detachment Of Device Component
1
1
Material Separation
1
1
Problem with Sterilization
1
1
Unraveled Material
1
1
Failure to Osseointegrate
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Damaged by Another Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient-Device Incompatibility
1
1
Material Fragmentation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
151
151
No Clinical Signs, Symptoms or Conditions
88
88
No Known Impact Or Consequence To Patient
54
54
Insufficient Information
24
24
No Information
11
11
No Patient Involvement
7
7
Foreign Body In Patient
3
3
Device Embedded In Tissue or Plaque
3
3
Tooth Fracture
2
2
Needle Stick/Puncture
1
1
Injury
1
1
Erythema
1
1
Bone Fracture(s)
1
1
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Pain
1
1
Tissue Damage
1
1
No Code Available
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ormco/Sybronendo
II
Nov-05-2012
2
Ultradent Products, Inc.
II
Jan-05-2016
-
-