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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, dental, with operative unit
Product CodeKLC
Regulation Number 872.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
DCI
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Structural Problem 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1
No Consequences Or Impact To Patient 1 1
Joint Dislocation 1 1
Electric Shock 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A-Dec Inc II Jun-25-2015
2 Pelton & Crane Company III Apr-09-2010
3 Pelton & Crane Company II Apr-01-2010
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