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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
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
AB ARDENT
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANAXDENT GMBH
  SUBSTANTIALLY EQUIVALENT 1
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
  SUBSTANTIALLY EQUIVALENT 1
APEX DENTAL MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BICON, LLC
  SUBSTANTIALLY EQUIVALENT 2
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN SRL
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
BREDENT GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 6
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 4
COSMEDENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS INC.
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS LLC
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DANVILLE MATERIALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DETAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
DISCUS DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DMG USA INC.
  SUBSTANTIALLY EQUIVALENT 1
DMG USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMP LTD
  SUBSTANTIALLY EQUIVALENT 3
DWS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
FIGARO CROWNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 5
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHENANO DENTAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 2
GREENWAY YW LLC
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC (MITSUI CHEMICALS GROUP)
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 6
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 4
JUNO DENTISTRY LP
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
KM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 2
KURARAY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 4
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
MERZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PAC-DENT INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PASCAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTRON CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PENTRON CLINICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PERFECT FIT CROWNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL PRODUCTS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RHONDIUM, LTD.
  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
SCHUETZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 3
SHOFU DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
SILMET LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SPRINTRAY INC.
  SUBSTANTIALLY EQUIVALENT 1
SWISSMEDITEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 24
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 195 195
2015 118 118
2016 143 143
2017 42 42
2018 8 8
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
Appropriate Term/Code Not Available 237 237
Device Operates Differently Than Expected 54 54
Patient-Device Incompatibility 49 49
Adverse Event Without Identified Device or Use Problem 36 36
Material Integrity Problem 31 31
Insufficient Information 28 28
Material Discolored 22 22
Device Contamination with Chemical or Other Material 21 21
Leak/Splash 13 13
Nonstandard Device 11 11
Improper Chemical Reaction 11 11
Failure To Adhere Or Bond 9 9
Loss of or Failure to Bond 9 9
Missing Value Reason 6 6
Improper Device Output 3 3
Material Separation 3 3
Smoking 2 2
Fracture 2 2
Material Fragmentation 2 2
Air Leak 2 2
Contamination 2 2
Crack 2 2
Material Disintegration 2 2
Fire 2 2
Melted 2 2
Migration or Expulsion of Device 2 2
Poor Quality Image 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Fluid/Blood Leak 1 1
Break 1 1
Output Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Incorrect Device Or Component Shipped 1 1
Material Distortion 1 1
Biocompatibility 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Deliver 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 301 301
No Information 63 63
Sensitivity of Teeth 37 37
No Known Impact Or Consequence To Patient 34 34
Hypersensitivity/Allergic reaction 34 34
Pain 19 19
Complaint, Ill-Defined 7 7
Reaction 6 6
Rash 6 6
Swelling 6 6
Increased Sensitivity 5 5
Discomfort 5 5
Tooth Fracture 5 5
Device Embedded In Tissue or Plaque 4 4
Burning Sensation 4 4
Failure of Implant 4 4
Unspecified Infection 4 4
Headache 3 3
Numbness 3 3
Missing Value Reason 3 3
Tissue Breakdown 3 3
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 2 2
Weight Changes 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Tissue Damage 2 2
Hair Loss 2 2
Erythema 2 2
Abscess 2 2
Anaphylactic Shock 1 1
Autoimmune Disorder 1 1
Bacterial Infection 1 1
Erosion 1 1
Burn(s) 1 1
Cellulitis 1 1
Chest Pain 1 1
Dyspnea 1 1
Fatigue 1 1
Inflammation 1 1
Itching Sensation 1 1
Nausea 1 1
Arthralgia 1 1
Joint Swelling 1 1
Malaise 1 1
Shock 1 1
Thyroid Problems 1 1
Local Reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Intraoperative Pain 1 1
Irregular Pulse 1 1
Confusion/ Disorientation 1 1
Blister 1 1
Localized Skin Lesion 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-08-2015
2 Ivoclar Vivadent, Inc. III Feb-21-2018
3 Kerr Corporation II Feb-28-2012
4 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Sep-19-2013
5 Kerr/pentron Dba Kerr Corporation And Pentron Clinical III Nov-03-2011
6 Patterson Dental Supply, Inc. II Dec-17-2010
7 RHONDIUM LIMITED II Dec-19-2019
8 Sybron Dental Specialties II Feb-13-2012
9 Sybron Dental Specialties II Feb-11-2012
10 Sybron Dental Specialties III Mar-02-2010
11 Ultradent Products, Inc. II Oct-02-2020
12 Voco GmbH II Oct-01-2019
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