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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device material, impression
Product CodeELW
Regulation Number 872.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 5
3M ESPE AG
  SUBSTANTIALLY EQUIVALENT 2
  1.  K133400  FLASH BITE
  2.  K140602  FLASH PENTA MB QUICK, FLASH MB QUICK
ARGES IMAGING, INC
  SUBSTANTIALLY EQUIVALENT 1
B&E KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLACKWELL DEVICE CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
CASCADES DEVICE CONSULTING ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
CAVEX HOLLAND B.V
  SUBSTANTIALLY EQUIVALENT 1
CAVEX HOLLAND BV
  SUBSTANTIALLY EQUIVALENT 1
CENTRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHEMOMENT MATERIALS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
COLTÈNE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS LLC
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC
  SUBSTANTIALLY EQUIVALENT 1
DENTPLY INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMP LTD
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 2
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 5
HRS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HYGEDENT INC
  SUBSTANTIALLY EQUIVALENT 1
HYGEDENT INC.
  SUBSTANTIALLY EQUIVALENT 3
IMICRYL DIS MALZEMELERI SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE PRODUCT BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IOS TECHNNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 3
LASCOD SPA
  SUBSTANTIALLY EQUIVALENT 2
META BIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILLENNIUM COMPANY LLC
  SUBSTANTIALLY EQUIVALENT 1
NANCHANG DENTAL BRIGHT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEOSIL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
NO STRESS IMPRESS LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM GERMANY GMBH
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSSTEM IMPLANT CO., LTD..
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTRON CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SEILGLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHERPA KOREA
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPOFADENTAL
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
VERICOM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU HUAER ELECTRO OPTICS TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHERMACK S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 35 35
2015 18 18
2016 15 15
2017 17 17
2018 14 14
2019 24 24
2020 8 8
2021 6 6
2022 9 9
2023 13 13
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 80 80
Adverse Event Without Identified Device or Use Problem 52 52
Improper or Incorrect Procedure or Method 9 9
Fitting Problem 9 9
Insufficient Information 8 8
Difficult to Remove 6 6
Appropriate Term/Code Not Available 5 5
Use of Device Problem 5 5
Device Operates Differently Than Expected 4 4
Off-Label Use 3 3
Material Distortion 3 3
Device Handling Problem 2 2
Device Appears to Trigger Rejection 2 2
Positioning Failure 2 2
Material Disintegration 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Failure To Adhere Or Bond 1 1
Complete Blockage 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Too Rigid or Stiff 1 1
Obstruction of Flow 1 1
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Physical Property Issue 1 1
Torn Material 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 65 65
Swelling 35 35
Reaction 32 32
No Code Available 12 12
Foreign Body In Patient 8 8
No Known Impact Or Consequence To Patient 7 7
Burning Sensation 6 6
Ulcer 5 5
Dyspnea 5 5
Rash 4 4
Tingling 4 4
Numbness 4 4
No Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Discomfort 3 3
Failure of Implant 3 3
Inflammation 2 2
Anaphylactic Shock 2 2
Itching Sensation 2 2
No Consequences Or Impact To Patient 2 2
Pain 2 2
Obstruction/Occlusion 2 2
Patient Problem/Medical Problem 2 2
Injury 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sore Throat 1 1
Device Embedded In Tissue or Plaque 1 1
Tooth Fracture 1 1
Skin Inflammation 1 1
Choking 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Abdominal Pain 1 1
Ulceration 1 1
Complaint, Ill-Defined 1 1
Laceration(s) 1 1
Nausea 1 1
Occlusion 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Shock 1 1
Apnea 1 1
Cardiac Arrest 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-18-2013
2 Clinician's Choice Dental Products Inc. II May-17-2022
3 Ivoclar Vivadent, Inc. II Dec-07-2016
4 Kerr Corporation II Nov-08-2012
5 Sybron Dental Specialties III Mar-02-2012
6 Ultradent Products, Inc. III Feb-13-2013
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