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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
Positioning Issue 52
Device displays error message 51
Device markings issue 49
Overheating of device or device component 23
Unintended energization 19
Device remains activated 12
Disassembly 8
Electrical issue 5
Mechanical issue 4
Leak 3
Unintended movement 2
Break 2
Fluid leak 2
Smoking 2
Unstable 2
Cut in material 2
Device operates differently than expected 2
Device unsafe to use in environment 1
Electrical power problem 1
Component falling 1
Migration of device or device component 1
Total Device Problems 244

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 0
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 Pelton & Crane Company II Mar-06-2012
3 William C. Domb, D.M.D., A Professional Corporation II May-09-2014

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