Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASIGA PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENATMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
EVODEN INDÚSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO
  SUBSTANTIALLY EQUIVALENT 1
FORMLABS OHIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HEYGEARS IMC., INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HULIANG(SHANGHAI) BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MGNEWTON , LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUEST DENTAL USA CORP.
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPRINTRAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN DENTAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 2 2
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Patient-Device Incompatibility 2 2
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Material Discolored 1 1
Material Deformation 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Failure of Implant 1 1
Metal Related Pathology 1 1
Asthma 1 1
Blister 1 1
Dysphagia/ Odynophagia 1 1
Swelling/ Edema 1 1
Ulcer 1 1

-
-