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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
Product CodeEBF
Regulation Number 872.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 2
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 2
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 5
DETAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
DWS S.R.L.
  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 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 2
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 2
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PERFECT FIT CROWNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL PRODUCTS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 3
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAREMCO DENTAL AG
  SUBSTANTIALLY EQUIVALENT 2
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPRINTRAY INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2019 11 11
2020 2 2
2021 2 2
2022 2 2
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Patient-Device Incompatibility 7 7
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 1 1
Biocompatibility 1 1
Off-Label Use 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 12 12
Rash 5 5
Discomfort 4 4
Sensitivity of Teeth 4 4
Pain 3 3
Burning Sensation 2 2
Swelling 2 2
Erythema 2 2
Hair Loss 2 2
Headache 2 2
Numbness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Weight Changes 2 2
Intraoperative Pain 1 1
Tissue Breakdown 1 1
No Code Available 1 1
Blister 1 1
Localized Skin Lesion 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Tooth Fracture 1 1
Irregular Pulse 1 1
Malaise 1 1
Fatigue 1 1
Abscess 1 1
Autoimmune Disorder 1 1
Chest Pain 1 1
Dyspnea 1 1
Thyroid Problems 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RHONDIUM LIMITED II Dec-19-2019
2 Ultradent Products, Inc. II Oct-02-2020
3 Voco GmbH II Oct-01-2019
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