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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
1. K193405
Simplant Digital Guide
MDR Year
MDR Reports
MDR Events
2020
183
183
2021
237
237
2022
189
192
2023
212
212
2024
226
226
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
282
282
Detachment of Device or Device Component
200
200
Separation Failure
186
186
Mechanical Problem
77
77
Adverse Event Without Identified Device or Use Problem
68
68
Malposition of Device
31
31
Use of Device Problem
30
30
Break
27
27
Material Deformation
24
24
Device Damaged by Another Device
23
23
Positioning Failure
18
18
Osseointegration Problem
12
12
Failure to Osseointegrate
11
11
Leak/Splash
11
11
Defective Device
10
10
Device Contamination with Chemical or Other Material
9
9
Positioning Problem
7
7
Separation Problem
6
6
Unexpected Therapeutic Results
5
5
Connection Problem
5
5
Product Quality Problem
4
4
No Apparent Adverse Event
4
4
Loss of Osseointegration
4
4
Device Markings/Labelling Problem
4
4
Inadequacy of Device Shape and/or Size
3
3
Insufficient Information
3
3
Difficult to Insert
3
3
Component Missing
3
3
Appropriate Term/Code Not Available
3
3
Patient-Device Incompatibility
2
2
Premature Separation
2
2
Tear, Rip or Hole in Device Packaging
2
2
Output Problem
2
2
Installation-Related Problem
2
2
Failure to Eject
2
2
Unintended Movement
2
2
Difficult or Delayed Separation
2
2
Device Handling Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Migration or Expulsion of Device
2
2
Device-Device Incompatibility
2
2
Component or Accessory Incompatibility
2
2
Complete Blockage
2
2
Inaccurate Information
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Lack of Effect
1
1
Missing Information
1
1
Structural Problem
1
1
Unsealed Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
591
594
Failure of Implant
198
198
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
Hematoma
8
8
Pain
8
8
Thrombosis/Thrombus
7
7
Osteopenia/ Osteoporosis
7
7
Unspecified Infection
7
7
Inflammation
5
5
Air Embolism
5
5
No Patient Involvement
5
5
Swelling/ Edema
4
4
Physical Asymmetry
4
4
Aspiration/Inhalation
4
4
Discomfort
4
4
Sinus Perforation
4
4
Abscess
3
3
Bruise/Contusion
2
2
Granuloma
2
2
Osteolysis
2
2
Sepsis
2
2
No Code Available
2
2
Pseudoaneurysm
2
2
Unspecified Tissue Injury
2
2
Inadequate Osseointegration
1
1
Taste Disorder
1
1
Paresthesia
1
1
Implant Pain
1
1
Dry Mouth
1
1
Speech Disorder
1
1
Vascular Dissection
1
1
Bone Fracture(s)
1
1
Headache
1
1
Ischemic Heart Disease
1
1
Numbness
1
1
Weight Changes
1
1
Sore Throat
1
1
Organ Dehiscence
1
1
Incompetent Cervix
1
1
Hypersensitivity/Allergic reaction
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
Aug-03-2021
6
Thommen Medical AG
II
Mar-20-2024
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