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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 1
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 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYGEDENT INC.
  SUBSTANTIALLY EQUIVALENT 2
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
NO STRESS IMPRESS LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
2019 24 24
2020 8 8
2021 6 6
2022 9 9
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 36 36
Adverse Event Without Identified Device or Use Problem 25 25
Improper or Incorrect Procedure or Method 6 6
Use of Device Problem 3 3
Difficult to Remove 2 2
Positioning Failure 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 1 1
Material Disintegration 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 37 37
Reaction 8 8
No Clinical Signs, Symptoms or Conditions 4 4
Swelling 4 4
Ulcer 4 4
Discomfort 3 3
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 3 3
No Code Available 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Consequences Or Impact To Patient 2 2
Dyspnea 2 2
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Rash 1 1
Sore Throat 1 1
Burning Sensation 1 1
Numbness 1 1
Tooth Fracture 1 1

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