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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, polishing, abrasive, oral cavity
Regulation Description Oral cavity abrasive polishing agent.
Product CodeEJR
Regulation Number 872.6030
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 10
2020 3 3
2021 6 6
2022 2 2
2023 3 3
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Patient-Device Incompatibility 8 8
Delivered as Unsterile Product 2 4
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Markings/Labelling Problem 1 1
Material Puncture/Hole 1 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 2
Device Dislodged or Dislocated 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 13 13
Anaphylactic Shock 3 3
Swelling/ Edema 3 3
Patient Problem/Medical Problem 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 2 4
Rash 2 2
Burning Sensation 2 2
Swelling 2 2
Sore Throat 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Local Reaction 1 1
Insufficient Information 1 1
Vomiting 1 1
Reaction 1 1
Caustic/Chemical Burns 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Young Dental Manufacturing I, LLC II Jun-13-2024
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