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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

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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