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TPLC
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show TPLC since
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Device
syringe, periodontic, endodontic, irrigating
Product Code
EIC
Regulation Number
872.4565
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
146
146
2020
35
35
2021
76
76
2022
11
11
2023
19
19
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
295
295
Insufficient Information
5
5
Inadequacy of Device Shape and/or Size
3
3
Entrapment of Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Fragmentation
1
1
Inaccurate Synchronization
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
126
126
No Clinical Signs, Symptoms or Conditions
116
116
No Consequences Or Impact To Patient
116
116
Insufficient Information
52
52
No Information
45
45
Device Embedded In Tissue or Plaque
20
20
Foreign Body In Patient
6
6
Perforation
2
2
Sinus Perforation
2
2
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stradis Medical, LLC dba Stradis Healthcare
II
Dec-14-2022
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