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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
2014 13 13
2015 10 10
2016 8 8
2017 4 4
2018 11 11
2021 1 1
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 35
Material Integrity Problem 11 11
Fracture 8 8
Use of Device Problem 3 3
Detachment of Device or Device Component 2 2
Shelf Life Exceeded 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loss of or Failure to Bond 1 1
Device Operates Differently Than Expected 1 1
Loose or Intermittent Connection 1 1
Pitted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
No Consequences Or Impact To Patient 21 21
No Clinical Signs, Symptoms or Conditions 8 8
No Information 5 5
No Patient Involvement 3 3
Tissue Damage 1 1
Injury 1 1

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