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TPLC
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show TPLC since
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Device
cement, dental
Product Code
EMA
Regulation Number
872.3275
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M COMPANY
SUBSTANTIALLY EQUIVALENT
1
3M DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
3M ESPE DENTAL PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
BISCO, INC.
SUBSTANTIALLY EQUIVALENT
1
DENTSCARE LTDA
SUBSTANTIALLY EQUIVALENT
1
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
1
DOXA DENTAL AB
SUBSTANTIALLY EQUIVALENT
1
GC AMERICA INC.
SUBSTANTIALLY EQUIVALENT
4
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
SUBSTANTIALLY EQUIVALENT
1
ITENA CLINICAL
SUBSTANTIALLY EQUIVALENT
1
KERR CORPORATION
SUBSTANTIALLY EQUIVALENT
1
KETTENBACH GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
KURARAY NORITAKE DENTAL INC.
SUBSTANTIALLY EQUIVALENT
2
META BIOMED CO., LTD
SUBSTANTIALLY EQUIVALENT
1
PARKELL, INC
SUBSTANTIALLY EQUIVALENT
1
PREVEST DENPRO LIMITED
SUBSTANTIALLY EQUIVALENT
1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
SUBSTANTIALLY EQUIVALENT
1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ULTRADENT PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
VERICOM CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VOCO GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2017
13
13
2018
4
4
2019
12
12
2020
5
5
2021
8
8
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
19
19
Adverse Event Without Identified Device or Use Problem
11
11
Appropriate Term/Code Not Available
6
6
Increased Sensitivity
6
6
Material Discolored
3
3
Unexpected Color
2
2
Loss of or Failure to Bond
1
1
Contamination
1
1
Hole In Material
1
1
Product Quality Problem
1
1
Use of Device Problem
1
1
Material Perforation
1
1
Output Problem
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
17
17
Pain
9
9
Sensitivity of Teeth
7
7
No Code Available
7
7
Swelling
6
6
Insufficient Information
5
5
Inflammation
3
3
Dyspnea
2
2
Rash
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Skin Irritation
2
2
Reaction
2
2
Shaking/Tremors
1
1
Skin Tears
1
1
Tissue Breakdown
1
1
Patient Problem/Medical Problem
1
1
No Known Impact Or Consequence To Patient
1
1
Local Reaction
1
1
Increased Sensitivity
1
1
Skin Discoloration
1
1
Burning Sensation
1
1
Dysphasia
1
1
Osteolysis
1
1
Hemorrhage/Bleeding
1
1
Syncope
1
1
Chest Pain
1
1
Irritation
1
1
Peeling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
II
Apr-29-2020
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