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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
Product CodeNDP
Regulation Number 872.3980
Device Class 1


Premarket Reviews
ManufacturerDecision
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
  1.  K190059  CEREC Guides
  2.  K193405  Simplant Digital Guide

MDR Year MDR Reports MDR Events
2018 279 279
2019 262 262
2020 183 183
2021 237 237
2022 192 195
2023 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 304 304
Separation Failure 236 236
Detachment of Device or Device Component 140 140
Adverse Event Without Identified Device or Use Problem 125 125
Mechanical Problem 90 90
Break 40 40
Malposition of Device 26 26
Use of Device Problem 22 22
Device Damaged by Another Device 18 18
Material Deformation 17 17
Leak/Splash 12 12
Positioning Failure 11 11
Defective Device 11 11
Osseointegration Problem 11 11
Positioning Problem 10 10
Separation Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Failure to Osseointegrate 8 8
Appropriate Term/Code Not Available 7 7
Premature Separation 6 6
Inaccurate Information 6 6
Device-Device Incompatibility 6 6
Device Markings/Labelling Problem 6 6
Defective Component 6 6
Component Missing 5 5
Unexpected Therapeutic Results 5 5
Connection Problem 5 5
Material Integrity Problem 5 5
No Apparent Adverse Event 5 5
Manufacturing, Packaging or Shipping Problem 5 6
Component Misassembled 4 4
Insufficient Information 4 4
Activation, Positioning or Separation Problem 4 4
Accessory Incompatible 4 4
Detachment Of Device Component 4 4
Migration or Expulsion of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Inadequacy of Device Shape and/or Size 3 3
Loss of Osseointegration 3 3
Patient-Device Incompatibility 3 3
Device Operates Differently Than Expected 3 3
Tear, Rip or Hole in Device Packaging 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Unintended Movement 2 2
Output Problem 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Unstable 2 2
Fitting Problem 2 4
Product Quality Problem 2 2
Nonstandard Device 2 2
Complete Blockage 2 2
Material Fragmentation 2 2
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Corroded 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1
Material Separation 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
No Pressure 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Missing Information 1 1
Deformation Due to Compressive Stress 1 1
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
Device Dislodged or Dislocated 1 1
Free or Unrestricted Flow 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 472 472
No Clinical Signs, Symptoms or Conditions 264 267
Failure of Implant 194 194
No Consequences Or Impact To Patient 71 71
No Code Available 56 56
Insufficient Information 45 45
Injury 34 34
Perforation 27 27
No Known Impact Or Consequence To Patient 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
No Patient Involvement 16 16
Foreign Body In Patient 13 13
Hemorrhage/Bleeding 10 10
Bacterial Infection 10 10
Unspecified Infection 9 9
Hematoma 8 8
Thrombosis/Thrombus 7 7
Osteopenia/ Osteoporosis 6 6
Air Embolism 5 5
Discomfort 4 4
Laceration(s) 4 4
Pain 4 4
Physical Asymmetry 4 4
Swelling/ Edema 3 3
Device Embedded In Tissue or Plaque 3 3
Nerve Damage 3 3
Osteolysis 3 3
Numbness 3 3
Aspiration/Inhalation 3 3
Abscess 3 3
Inflammation 3 3
Bone Fracture(s) 2 2
Granuloma 2 2
Bruise/Contusion 2 2
Pseudoaneurysm 2 2
Sepsis 2 2
Sinus Perforation 2 2
Pocket Erosion 1 1
Inadequate Osseointegration 1 1
Ischemic Heart Disease 1 1
Organ Dehiscence 1 1
Edema 1 1
Erosion 1 1
Wound Dehiscence 1 1
Incompetent Cervix 1 1
Fibrosis 1 1
Vascular Dissection 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Unspecified Tissue Injury 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Implant Direct Sybron Manufacturing, LLC II Jan-08-2020
2 Implant Direct Sybron Manufacturing, LLC II Oct-31-2019
3 Implant Direct Sybron Manufacturing, LLC II Oct-09-2018
4 Keystone Dental Inc II Apr-19-2018
5 Nobel Biocare Usa Llc II Feb-19-2020
6 Paltop Advanced Dental Solutions Ltd II Oct-04-2021
7 Straumann USA LLC II Aug-03-2021
8 Thommen Medical AG II May-22-2019
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