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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device varnish, cavity
Product CodeLBH
Regulation Number 872.3260
Device Class 2


Premarket Reviews
ManufacturerDecision
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC
  SUBSTANTIALLY EQUIVALENT 1
DR. COLLINS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELEVATE ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU BEOGENE BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LARGENT HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 2
SANGI CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIFIC PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 10 10
2021 15 15
2022 7 7
2023 8 8
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Patient-Device Incompatibility 13 13
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Biocompatibility 2 2
Inadequate Instructions for Healthcare Professional 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 16 16
Pain 11 11
Hypersensitivity/Allergic reaction 10 10
Swelling/ Edema 9 9
Local Reaction 8 8
Caustic/Chemical Burns 7 7
Inflammation 5 5
Vomiting 5 5
Swelling 5 5
Reaction 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Skin Inflammation/ Irritation 4 4
Ulcer 4 4
Headache 4 4
Nausea 3 3
Rash 3 3
Erythema 3 3
Skin Discoloration 2 2
Burn(s) 2 2
Numbness 2 2
No Code Available 1 1
Emotional Changes 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
Itching Sensation 1 1
Tooth Fracture 1 1
Myalgia 1 1
No Known Impact Or Consequence To Patient 1 1
Pallor 1 1
Congenital Defect/Deformity 1 1
Anaphylactic Shock 1 1
Dysphagia/ Odynophagia 1 1
Cough 1 1
Contact Dermatitis 1 1
Skin Tears 1 1
Bacterial Infection 1 1
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Keystone Industries II Sep-12-2023
2 Ultradent Products, Inc. II Jan-03-2019
3 Young Dental Manufacturing Co, LLC II Dec-09-2019
4 Young Dental Manufacturing I, LLC II Jun-08-2023
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