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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device crown and bridge, temporary, resin
Product CodeEBG
Regulation Number 872.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLAGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K200039  P pro Crown & Bridge
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DETAX GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
DMP DENTAL INDUSTRY S.A.
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTEN MATERIALS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HEYGEARS IMC. INC
  SUBSTANTIALLY EQUIVALENT 1
HUGE DENTAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HULIANG(SHANGHAI) BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MGNEWTON LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEW STETIC S.A.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO3DURE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
QUEST DENTAL USA CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 2 2
2021 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 10 10
Adverse Event Without Identified Device or Use Problem 7 7
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 12 12
Swelling 6 6
Reaction 5 5
Blister 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ulcer 1 1
Asthma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Talladium Inc III Dec-01-2020
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