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TPLC
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Device
wire, orthodontic
Product Code
DZC
Regulation Number
872.5410
Device Class
1
Premarket Reviews
Manufacturer
Decision
ORMCO CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2016
4
4
2017
1
1
2018
2
2
2019
6
6
2020
1
1
2021
3
3
2022
7
7
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6
6
Patient Device Interaction Problem
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Insufficient Information
3
3
Material Fragmentation
3
3
Patient-Device Incompatibility
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
1
1
Migration or Expulsion of Device
1
1
Migration
1
1
Biocompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
6
6
Hypersensitivity/Allergic reaction
4
4
Device Embedded In Tissue or Plaque
4
4
No Code Available
3
3
No Information
3
3
Abdominal Pain
1
1
Unspecified Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Skin Infection
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Inflammation
1
1
No Known Impact Or Consequence To Patient
1
1
Reaction
1
1
Glossitis
1
1
Internal Organ Perforation
1
1
Sensitivity of Teeth
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Highland Metals, Inc.
II
Feb-03-2014
2
Ormco Corporation
II
Jan-11-2012
3
Ormco/Sybronendo
II
Nov-30-2015
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