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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
DR. COLLINS, 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
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
JASBERRY HEALTHCARE PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LARGENT HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 2
NAGY ORAL TECHNOLOGY QINHUANGDAO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SANGI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIFIC PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
THEODENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 15 15
2022 7 7
2023 8 8
2024 6 6
2025 7 7
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 19 19
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Patient Device Interaction Problem 3 3
Patient-Device Incompatibility 2 2
Biocompatibility 2 2
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 16 16
Hypersensitivity/Allergic reaction 12 12
Pain 10 10
Swelling/ Edema 10 10
Local Reaction 7 7
Vomiting 6 6
Caustic/Chemical Burns 6 6
Headache 5 5
Skin Inflammation/ Irritation 4 4
Inflammation 4 4
Anaphylactoid / Anaphylaxis 4 4
Ulcer 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Nausea 3 3
Rash 3 3
Burn(s) 2 2
Erythema 2 2
Emotional Changes 1 1
Memory Loss/Impairment 1 1
Dizziness 1 1
Itching Sensation 1 1
Myalgia 1 1
Tooth Fracture 1 1
Skin Discoloration 1 1
No Known Impact Or Consequence To Patient 1 1
Pallor 1 1
Swelling 1 1
Congenital Defect/Deformity 1 1
Reaction 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 Young Dental Manufacturing I, LLC II Jun-08-2023
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