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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 98
Device displays error message 69
Positioning Issue 52
Overheating of device or device component 39
Unintended energization 33
Device remains activated 18
Disassembly 14
Unintended movement 8
Cut in material 6
Electrical issue 5
Leak 4
Mechanical issue 4
Break 4
Smoking 3
Device operates differently than expected 3
Unstable 2
Fluid leak 2
Migration of device or device component 1
Misassembled 1
Misconnection 1
Metal shedding debris 1
Device Issue 1
Component falling 1
Device unsafe to use in environment 1
Electrical power problem 1
Total Device Problems 372

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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