• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device crown and bridge, temporary, resin
Regulation Description Temporary crown and bridge resin.
Product CodeEBG
Regulation Number 872.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY, 3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
BLUE DENT DENTAL
  SUBSTANTIALLY EQUIVALENT 1
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTALPLUS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARVEST DENTAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNION DENTAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS,LLC ALSO DBA ZEST ANCHORS,INC. AND ZEST ANCHORS
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Patient-Device Incompatibility 7
Insufficient Information 5
Malposition of device 4
Adverse Event Without Identified Device or Use Problem 3
Structural Problem 2
Fracture 2
Difficult To Position 2
Positioning Failure 2
Device Operates Differently Than Expected 2
Positioning Problem 2
Inadequacy of Device Shape and/or Size 2
Defective Device 2
Break 1
Appropriate Term/Code Not Available 1
Defective Component 1
Device-Device Incompatibility 1
Total Device Problems 39


-
-