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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resin, denture, relining, repairing, rebasing
Regulation Description Denture relining, repairing, or rebasing resin.
Product CodeEBI
Regulation Number 872.3760
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 2
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 11
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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