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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dam, rubber
Product CodeEIE
Regulation Number 872.6300
Device Class 1


Premarket Reviews
ManufacturerDecision
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAVRIK DENTAL SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 2 2
2018 4 4
2019 2 2
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 5 5
Material Integrity Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Patient-Device Incompatibility 3 3
Break 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Hypersensitivity/Allergic reaction 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Swelling 2 2
Caustic/Chemical Burns 2 2
Urticaria 1 1
Gastroesophageal Burn 1 1
Itching Sensation 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Coltene Whaledent Inc II Aug-06-2014
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