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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device varnish, cavity
Regulation Description Cavity varnish.
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
CENTRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATE ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
GREENMARK BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU BEOGENE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
JASBERRY HEALTHCARE PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SANGI CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
THEODENT, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 15 15
2022 7 7
2023 8 8
2024 6 6
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Patient-Device Incompatibility 10 10
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Biocompatibility 2 2
Patient Device Interaction Problem 2 2
Human-Device Interface Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 13 13
Hypersensitivity/Allergic reaction 11 11
Swelling/ Edema 9 9
Local Reaction 6 6
Pain 6 6
Skin Inflammation/ Irritation 4 4
Anaphylactoid 4 4
Vomiting 4 4
Headache 4 4
Inflammation 3 3
Caustic/Chemical Burns 3 3
Ulcer 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Nausea 2 2
Rash 2 2
Erythema 2 2
Emotional Changes 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
Itching Sensation 1 1
Tooth Fracture 1 1
Myalgia 1 1
Burn(s) 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
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Keystone Industries II Sep-12-2023
2 Young Dental Manufacturing I, LLC II Jun-08-2023
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