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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bur, dental
Regulation Description Dental bur.
Product CodeEJL
Regulation Number 872.3240
Device Class 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 19 19
2023 9 9
2024 25 25
2025 56 57
2026 20 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 55 55
Fracture 21 23
Detachment of Device or Device Component 16 16
Material Fragmentation 5 5
Insufficient Device Problem Information 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Device Dislodged or Dislocated 2 2
Sharp Edges 1 1
Mechanical Problem 1 1
Packaging Problem 1 1
Misconnection 1 1
Device Markings/Labelling Problem 1 1
No Apparent Adverse Event 1 1
Overheating of Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 70
Insufficient Information 33 33
Foreign Body In Patient 30 30
Laceration(s) 11 11
Device Embedded In Tissue or Plaque 5 5
Abrasion 3 3
Numbness 2 2
Burn(s) 2 2
Pain 2 2
Needle Stick/Puncture 2 2
Failure of Implant 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Unspecified Tissue Injury 1 1
Perforation 1 1
Tissue Breakdown 1 1
Sinus Perforation 1 1
Tooth Loss 1 1
Swelling/ Edema 1 1
Superficial (First Degree) Burn 1 1
Aspiration/Inhalation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brasseler USA I Lp II Feb-07-2024
2 Premier Dental Products Co II Mar-21-2025
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