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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, rubber dam
Product CodeEEF
Regulation Number 872.6300
Device Class 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 11 11
2021 1 1
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 11 11
Break 9 9
Fracture 8 8
Shelf Life Exceeded 2 2
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loss of or Failure to Bond 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 8 8
No Information 2 2
Injury 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dentech Corp. II May-25-2021
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