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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, implant, dental, endosseous
Regulation Description Endosseous dental implant accessories.
Product CodeNDP
Regulation Number 872.3980
Device Class 1


Premarket Reviews
ManufacturerDecision
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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