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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device abutment, implant, dental, endosseous
Regulation Description Endosseous dental implant abutment.
Definition To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Product CodeNHA
Regulation Number 872.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
A.B DENTAL DEVICE LTD.
  SUBSTANTIALLY EQUIVALENT 1
A.B. DENTAL DEVICE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACHIMHAI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET 3I
  SUBSTANTIALLY EQUIVALENT 3
BIOMET 3I LLC
  SUBSTANTIALLY EQUIVALENT 2
BLUE SKY BIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BUCKEYE MEDICAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 4
DENTALPOINT AG
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 11
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 2
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ELEGANT DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELOS MEDTECH PINOL A/S
  SUBSTANTIALLY EQUIVALENT 6
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN INC.
  SUBSTANTIALLY EQUIVALENT 2
IMAGINE MILLING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING , LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOBIOSURG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 21
INTEGRATED DENTAL SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 2
IVORY SUPER HOLDCO, INCP.
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 4
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
  SUBSTANTIALLY EQUIVALENT 2
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 4
MEGAGEN IMPLANT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIS IMPLANTS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIT GLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 8
NOBEL BIOCARE AG
  SUBSTANTIALLY EQUIVALENT 1
OPEN IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 3
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHEIN'83 SRL
  SUBSTANTIALLY EQUIVALENT 1
RODO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHINHUNG MST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOADCO S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 3
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC (ON BEHALF OF INSTITUT STRAUMANN AG)
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC (ON BEHALF OF INSTITUT STRAUMANN AG)
  SUBSTANTIALLY EQUIVALENT 1
SURGIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SWEDEN & MARTINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
TALLADIUM ESPANA, SL
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 5
TRUABUTMENT
  SUBSTANTIALLY EQUIVALENT 1
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 8
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 577 577
2018 590 590
2019 530 530
2020 458 506
2021 538 764

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1467 1659
Unintended Movement 300 300
Mechanical Problem 228 228
Positioning Failure 191 191
Migration or Expulsion of Device 134 134
Failure to Advance 69 69
Separation Failure 60 60
Break 60 60
Positioning Problem 48 48
Failure to Osseointegrate 35 35
Loss of Osseointegration 22 22
Adverse Event Without Identified Device or Use Problem 20 20
Manufacturing, Packaging or Shipping Problem 16 16
Inaccurate Information 13 13
Component Misassembled 10 10
Detachment of Device or Device Component 10 10
Patient-Device Incompatibility 9 9
Osseointegration Problem 9 9
Device Markings/Labelling Problem 8 8
Device Damaged by Another Device 7 7
Unsealed Device Packaging 7 7
Use of Device Problem 6 68
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Product Quality Problem 5 5
Loose or Intermittent Connection 5 5
Naturally Worn 4 4
Insufficient Information 3 64
Appropriate Term/Code Not Available 3 3
Missing Information 3 3
Output Problem 3 20
Nonstandard Device 3 3
Component Missing 3 3
Device Issue 3 3
Defective Device 3 3
Defective Component 2 2
Entrapment of Device 2 2
Detachment Of Device Component 2 2
Component Incompatible 2 2
Difficult to Remove 2 2
Misassembled 2 2
Device Operates Differently Than Expected 2 2
Contamination /Decontamination Problem 2 2
Component or Accessory Incompatibility 2 2
Connection Problem 2 62
Separation Problem 2 2
Misassembled During Installation 1 1
Incomplete or Inadequate Connection 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 4
Misconnection 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Corroded 1 1
Structural Problem 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Delivered as Unsterile Product 1 1
Failure To Adhere Or Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1885 1933
No Clinical Signs, Symptoms or Conditions 356 373
Failure of Implant 130 130
No Code Available 85 85
No Known Impact Or Consequence To Patient 80 80
No Consequences Or Impact To Patient 54 54
Pain 51 51
Inflammation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
No Patient Involvement 30 30
Insufficient Information 26 235
Discomfort 23 23
Osteopenia/ Osteoporosis 21 21
Unspecified Infection 19 19
Tissue Damage 10 10
Device Embedded In Tissue or Plaque 9 9
Difficulty Chewing 7 7
Fibrosis 6 6
Missing Value Reason 5 5
Impaired Healing 5 5
Edema 5 5
Granuloma 4 4
Bone Fracture(s) 3 3
Tinnitus 3 3
Osteolysis 2 2
Injury 2 2
Hemorrhage/Bleeding 2 2
Abscess 2 2
Rash 2 2
Bruxism 2 2
Foreign Body In Patient 2 2
Tooth Fracture 2 2
Palpitations 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1
Alteration In Body Temperature 1 1
Swelling/ Edema 1 1
Not Applicable 1 1
Seizures 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Swelling 1 1
Thyroid Problems 1 1
Irritation 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 1 1
Purulent Discharge 1 1
Fatigue 1 1
Headache 1 1
Joint Dislocation 1 1
Reaction 1 1
Fungal Infection 1 1
Sensitivity of Teeth 1 1
Visual Impairment 1 1
Weakness 1 1
Burning Sensation 1 1
Dysphasia 1 1
Sinus Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Oct-08-2020
2 Biomet 3i, LLC II Feb-26-2020
3 Biomet 3i, LLC II Aug-02-2019
4 Implant Direct Sybron Manufacturing LLC II Feb-10-2020
5 Implant Direct Sybron Manufacturing, LLC II Mar-22-2018
6 Implant Direct Sybron Manufacturing, LLC II Feb-06-2018
7 Implant Direct Sybron Manufacturing, LLC II Oct-03-2017
8 Keystone Dental Inc II Feb-14-2018
9 Nobel Biocare Procera LLC II May-25-2021
10 Nobel Biocare Usa Llc II Jun-03-2020
11 Nobel Biocare Usa Llc II May-04-2020
12 Nobel Biocare Usa Llc II Jul-23-2018
13 Southern Implants, (Pty.) Ltd. II Apr-16-2018
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