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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 material, tooth shade, resin
Regulation Description Tooth shade resin material.
Product CodeEBF
Regulation Number 872.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY, 3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
BICON, LLC
  SUBSTANTIALLY EQUIVALENT 2
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREDENT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
COLTENE HOLDING AG
  SUBSTANTIALLY EQUIVALENT 5
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GC CORP.
  SUBSTANTIALLY EQUIVALENT 4
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 3
JUNO DENTISTRY LP
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
KM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
MERZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC., SEPTODONT
  SUBSTANTIALLY EQUIVALENT 1
PARKELL INC
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK
  SUBSTANTIALLY EQUIVALENT 3
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 9
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Appropriate Term/Code Not Available 236
Patient-Device Incompatibility 22
Adverse Event Without Identified Device or Use Problem 12
Missing Value Reason 6
Insufficient Information 2
Fracture 2
Nonstandard device 1
Off-Label Use 1
Failure To Adhere Or Bond 1
Unintended Ejection 1
Device Operates Differently Than Expected 1
Torn Material 1
Loss of or Failure to Bond 1
Material Integrity Problem 1
Total Device Problems 288

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-08-2015
2 Ivoclar Vivadent, Inc. III Feb-21-2018
3 Voco Chemie Gmbh II Oct-01-2019

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