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TPLC
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Device
accessories, implant, dental, endosseous
Regulation Description
Endosseous dental implant accessories.
Product Code
NDP
Regulation Number
872.3980
Device Class
1
Premarket Reviews
Manufacturer
Decision
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
183
183
2021
237
237
2022
189
192
2023
212
212
2024
226
226
2025
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
293
293
Detachment of Device or Device Component
205
205
Separation Failure
189
189
Mechanical Problem
78
78
Adverse Event Without Identified Device or Use Problem
68
68
Use of Device Problem
31
31
Malposition of Device
31
31
Break
28
28
Device Damaged by Another Device
25
25
Material Deformation
24
24
Positioning Failure
18
18
Osseointegration Problem
12
12
Failure to Osseointegrate
11
11
Defective Device
11
11
Leak/Splash
11
11
Device Contamination with Chemical or Other Material
9
9
Positioning Problem
7
7
Separation Problem
6
6
Connection Problem
5
5
Unexpected Therapeutic Results
5
5
Loss of Osseointegration
4
4
Device Markings/Labelling Problem
4
4
No Apparent Adverse Event
4
4
Product Quality Problem
4
4
Failure to Eject
3
3
Improper or Incorrect Procedure or Method
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Inadequacy of Device Shape and/or Size
3
3
Difficult to Insert
3
3
Component Missing
3
3
Premature Separation
2
2
Inaccurate Information
2
2
Component or Accessory Incompatibility
2
2
Installation-Related Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Labelling, Instructions for Use or Training Problem
2
2
Difficult or Delayed Separation
2
2
Device Handling Problem
2
2
Device-Device Incompatibility
2
2
Structural Problem
2
2
Migration or Expulsion of Device
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Output Problem
2
2
Unintended Movement
2
2
Patient-Device Incompatibility
2
2
Complete Blockage
2
2
Compatibility Problem
1
1
Failure to Cut
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
612
615
Failure of Implant
203
203
No Information
117
117
Insufficient Information
54
54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
25
25
No Consequences Or Impact To Patient
16
16
Foreign Body In Patient
14
14
Injury
14
14
Perforation
13
13
Bacterial Infection
10
10
Hemorrhage/Bleeding
10
10
Laceration(s)
9
9
No Known Impact Or Consequence To Patient
9
9
Pain
8
8
Hematoma
8
8
Unspecified Infection
7
7
Thrombosis/Thrombus
7
7
Osteopenia/ Osteoporosis
7
7
No Patient Involvement
5
5
Inflammation
5
5
Air Embolism
5
5
Sinus Perforation
4
4
Aspiration/Inhalation
4
4
Discomfort
4
4
Swelling/ Edema
4
4
Physical Asymmetry
4
4
Abscess
3
3
Granuloma
2
2
No Code Available
2
2
Osteolysis
2
2
Sepsis
2
2
Bruise/Contusion
2
2
Unspecified Tissue Injury
2
2
Pseudoaneurysm
2
2
Fibrosis
1
1
Sore Throat
1
1
Headache
1
1
Erosion
1
1
Pocket Erosion
1
1
Tissue Breakdown
1
1
Incompetent Cervix
1
1
Distress
1
1
Device Embedded In Tissue or Plaque
1
1
Organ Dehiscence
1
1
Perforation of Vessels
1
1
Numbness
1
1
Nerve Damage
1
1
Burning Sensation
1
1
Paresthesia
1
1
Implant Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Implant Direct Sybron Manufacturing, LLC
II
Jan-08-2020
2
Nobel Biocare Usa Llc
II
Feb-19-2020
3
Paltop Advanced Dental Solutions Ltd
II
Oct-04-2021
4
Preat Corp
II
Aug-19-2024
5
Straumann USA LLC
II
Apr-14-2025
6
Straumann USA LLC
II
Aug-03-2021
7
Thommen Medical AG
II
Mar-20-2024
8
TruAbutment Inc.
II
Mar-11-2025
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