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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.E.I.B.MED
  SUBSTANTIALLY EQUIVALENT 1
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 2
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 4
DETAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
DSI DENTAL SOLUTIONS LTD
  SUBSTANTIALLY EQUIVALENT 1
DWS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
EDELWEISS DENTISTRY PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHENANO DENTAL S.L.
  SUBSTANTIALLY EQUIVALENT 2
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 3
MEDICLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERFECT FIT CROWNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL PRODUCTS COMPANY
  SUBSTANTIALLY EQUIVALENT 2
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 4
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAREMCO DENTAL AG
  SUBSTANTIALLY EQUIVALENT 3
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN PIOCREAT 3D TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPRINTRAY INC.
  SUBSTANTIALLY EQUIVALENT 2
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 2 2
2021 2 2
2022 2 2
2023 8 8
2024 5 5
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Patient-Device Incompatibility 6 6
Break 1 1
Patient Device Interaction Problem 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 9 9
Rash 3 3
Discomfort 3 3
Weight Changes 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Numbness 2 2
Headache 2 2
Sensitivity of Teeth 2 2
Unspecified Infection 1 1
Fatigue 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Itching Sensation 1 1
Blister 1 1
Localized Skin Lesion 1 1
Autoimmune Disorder 1 1
Burning Sensation 1 1
Chest Pain 1 1
Erythema 1 1
Swelling 1 1
Insufficient Information 1 1
Dyspnea 1 1
Pain 1 1
Swelling/ Edema 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ultradent Products, Inc. II Sep-06-2024
2 Ultradent Products, Inc. II Oct-02-2020
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