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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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

Device Problems
No Known Device Problem 11
Patient-device incompatibility 6
Inadequate instructions for healthcare professional 2
Use of Device Issue 1
Device operates differently than expected 1
Total Device Problems 21

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 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CMP Industries, Llc II Jun-29-2016
2 CMP Industries, Llc II Jun-29-2016
3 CMP Industries, Llc II Mar-09-2016

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