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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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Device material, impression
Product CodeELW
Regulation Number 872.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
B&E KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEMOMENT MATERIALS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
COLTÈNE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 2
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K181011  AIM2
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HRS CO., LTD.
  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
LASCOD SPA
  SUBSTANTIALLY EQUIVALENT 1
NANCHANG DENTAL BRIGHT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEOSIL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NO STRESS IMPRESS LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSSTEM IMPLANT CO., LTD..
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU HUAER ELECTRO OPTICS TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 17 17
2018 14 14
2019 24 24
2020 8 8
2021 6 6
2022 9 9
2023 13 13
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 53 53
Adverse Event Without Identified Device or Use Problem 37 37
Improper or Incorrect Procedure or Method 7 7
Difficult to Remove 4 4
Use of Device Problem 4 4
Appropriate Term/Code Not Available 3 3
Positioning Failure 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 2 2
Material Disintegration 1 1
Loose or Intermittent Connection 1 1
Contamination /Decontamination Problem 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Device Handling Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 52 52
Reaction 11 11
Swelling 9 9
Burning Sensation 5 5
Dyspnea 5 5
Ulcer 5 5
No Code Available 5 5
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Discomfort 3 3
Patient Problem/Medical Problem 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inflammation 2 2
Itching Sensation 2 2
Tingling 2 2
No Consequences Or Impact To Patient 2 2
Pain 2 2
Rash 2 2
Local Reaction 1 1
Respiratory Distress 1 1
Laceration(s) 1 1
Irritation 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
Anaphylactic Shock 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Sore Throat 1 1
Numbness 1 1
Tooth Fracture 1 1
Skin Inflammation 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinician's Choice Dental Products Inc. II May-17-2022
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