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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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New Search Show TPLC since Back To Search Results
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
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CMP INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 1
JUVORA
  SUBSTANTIALLY EQUIVALENT 2
MERZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
  SUBSTANTIALLY EQUIVALENT 1
PROTECH PROFESSIONAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE MYERSON COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
THERMOPLASTIC COMFORT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1
WHIP-MIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS,LLC ALSO DBA ZEST ANCHORS,INC. AND ZEST ANCHORS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 13
Patient-Device Incompatibility 7
Use of Device Problem 2
Inadequate Instructions for Healthcare Professional 2
Device Operates Differently Than Expected 1
Insufficient Information 1
Device Handling Problem 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 28

Recalls
Manufacturer Recall Class Date Posted
1 CMP Industries, Llc II Oct-30-2018
2 CMP Industries, Llc II Jun-29-2016
3 CMP Industries, Llc II Jun-29-2016
4 CMP Industries, Llc II Mar-09-2016

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