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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scaler, ultrasonic
Regulation Description Ultrasonic scaler.
Product CodeELC
Regulation Number 872.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 3
HU-FRIEDY
  SUBSTANTIALLY EQUIVALENT 3
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 5
SATELEC
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Overheating of device or device component 55
Break 54
Material separation 12
Detachment of device component 7
Volume accuracy issue 6
Temperature issue 6
Fracture 5
Material fragmentation 3
Device operates differently than expected 3
Inadequate user interface 2
Melted 2
Material integrity issue 1
No flow 1
No Known Device Problem 1
No Information 1
Out-of-box failure 1
Hole in material 1
Electrical issue 1
Inappropriate shock 1
Peeled 1
Total Device Problems 164

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Nakanishi Inc. II Aug-26-2016

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