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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, operative dental
Regulation Description Dental operative unit and accessories.
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 24
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRO-OPTICAL SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KAVO
  SUBSTANTIALLY EQUIVALENT 1
LUMALITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROGENY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI DENTAL INSTRUMENT FACTORY
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 3
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 4
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device markings issue 83
Device displays error message 60
Positioning Issue 52
Overheating of device or device component 30
Unintended energization 29
Device remains activated 18
Disassembly 13
Electrical issue 5
Leak 4
Mechanical issue 4
Cut in material 4
Break 3
Smoking 3
Device operates differently than expected 3
Unintended movement 2
Unstable 2
Fluid leak 2
Migration of device or device component 1
Misassembled 1
Misconnection 1
Device Issue 1
Component falling 1
Device unsafe to use in environment 1
Electrical power problem 1
Total Device Problems 324

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 1 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ASI Medical, Inc. II Dec-19-2013
2 Danville Materials, Inc. II Aug-12-2016
3 Pelton & Crane Company II Mar-06-2012
4 William C. Domb, D.M.D., A Professional Corporation II May-09-2014

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