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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
  SUBSTANTIALLY EQUIVALENT 2
3M COMPANY, 3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
BICON, LLC
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREDENT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
COLTENE HOLDING AG
  SUBSTANTIALLY EQUIVALENT 5
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 3
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
GC CORP.
  SUBSTANTIALLY EQUIVALENT 5
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 2
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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
PARKELL INC
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK
  SUBSTANTIALLY EQUIVALENT 2
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 11
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 118 118
2016 143 143
2017 42 42
2018 8 8
2019 11 11
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 237 237
Patient-Device Incompatibility 27 27
Adverse Event Without Identified Device or Use Problem 19 19
Device Operates Differently Than Expected 7 7
Missing Value Reason 6 6
Insufficient Information 6 6
Material Discolored 6 6
Nonstandard Device 5 5
Material Integrity Problem 4 4
Leak/Splash 3 3
Failure To Adhere Or Bond 2 2
Fracture 2 2
Melted 2 2
Migration or Expulsion of Device 2 2
Air Leak 2 2
Fire 2 2
Smoking 2 2
Expiration Date Error 1 1
Output Problem 1 1
Fluid Leak 1 1
Loss of or Failure to Bond 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Wire 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 253 253
Sensitivity of Teeth 17 17
Pain 12 12
Hypersensitivity/Allergic reaction 11 11
No Information 8 8
Complaint, Ill-Defined 5 5
Rash 4 4
Swelling 4 4
No Known Impact Or Consequence To Patient 3 3
Missing Value Reason 3 3
Unspecified Infection 3 3
Burning Sensation 3 3
Discomfort 3 3
Reaction 3 3
Tooth Fracture 2 2
Hair Loss 2 2
Patient Problem/Medical Problem 2 2
Abscess 2 2
Erosion 1 1
Burn(s) 1 1
Erythema 1 1
Increased Sensitivity 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Malaise 1 1
Numbness 1 1
Irregular Pulse 1 1
Arthralgia 1 1
Joint Swelling 1 1
Headache 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Local Reaction 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Confusion/ Disorientation 1 1
Intraoperative Pain 1 1
Tissue Breakdown 1 1
Nausea 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 RHONDIUM LIMITED II Dec-19-2019
4 Ultradent Products, Inc. II Oct-02-2020
5 Voco Chemie Gmbh II Oct-01-2019
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