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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
Regulation Description Rubber dam and accessories.
Product CodeEEF
Regulation Number 872.6300
Device Class 1

MDR Year MDR Reports MDR Events
2016 8 8
2017 4 4
2018 11 11
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Material Integrity Problem 11 11
Adverse Event Without Identified Device or Use Problem 2 2
Shelf Life Exceeded 2 2
Detachment of Device or Device Component 2 2
Loss of or Failure to Bond 1 1
Use of Device Problem 1 1
Fracture 1 1
Pitted 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Consequences Or Impact To Patient 13 13
No Information 2 2
Tissue Damage 1 1
Injury 1 1
No Patient Involvement 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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