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TPLC
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show TPLC since
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2024
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Device
varnish, cavity
Product Code
LBH
Regulation Number
872.3260
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
JASBERRY HEALTHCARE PRIVATE LIMITED
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
Swelling
5
5
Vomiting
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
Emotional Changes
1
1
No Code Available
1
1
Memory Loss/Impairment
1
1
Dizziness
1
1
Itching Sensation
1
1
Myalgia
1
1
Tooth Fracture
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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