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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
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 2
ACHIMHAI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
B.T.I. BIOTECHNOLOGY INSTITUTE, SL.
  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
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 4
DENTALPOINT AG
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 12
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
IMPLANT PROTESIS DENTAL 2004 S.L
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT SOLUTIONS PTY LTD (AKA OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT SOLUTIONS PTY LTD (OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
INNOBIOSURG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
INNOVATIVE PRODUCT BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 24
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
KEYSTONE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 4
MEGAGEN IMPLANT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MIS IMPLANTS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIT GLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOSS LTD
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 8
NOBEL BIOCARE AG
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
NORIS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
OPEN IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 3
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 2
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 8
TRUABUTMENT
  SUBSTANTIALLY EQUIVALENT 1
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 9
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 577 577
2018 590 590
2019 530 530
2020 458 506
2021 547 780
2022 413 583

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1724 2059
Unintended Movement 388 388
Mechanical Problem 238 242
Positioning Failure 223 223
Migration or Expulsion of Device 134 134
Failure to Advance 69 69
Separation Failure 63 63
Break 60 60
Positioning Problem 48 48
Failure to Osseointegrate 41 44
Loss of Osseointegration 25 25
Adverse Event Without Identified Device or Use Problem 24 24
Manufacturing, Packaging or Shipping Problem 16 19
Inaccurate Information 13 13
Use of Device Problem 13 78
Detachment of Device or Device Component 11 11
Component Misassembled 10 10
Connection Problem 9 86
Patient-Device Incompatibility 9 9
Osseointegration Problem 9 9
Loose or Intermittent Connection 9 14
Device Markings/Labelling Problem 8 8
Device Damaged by Another Device 7 7
Unsealed Device Packaging 7 7
Product Quality Problem 6 7
Loosening of Implant Not Related to Bone-Ingrowth 6 7
Appropriate Term/Code Not Available 4 12
Naturally Worn 4 4
Insufficient Information 3 64
Separation Problem 3 3
Missing Information 3 3
Output Problem 3 20
Defective Device 3 3
Component Missing 3 3
Device Issue 3 3
Nonstandard Device 3 3
Misassembled 2 2
Detachment Of Device Component 2 2
Component Incompatible 2 2
Entrapment of Device 2 2
Defective Component 2 2
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Device Operates Differently Than Expected 2 2
Contamination /Decontamination Problem 2 2
Component or Accessory Incompatibility 2 2
Structural Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1
Unintended Compatibility 1 10
Misassembled During Installation 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 4
Fitting Problem 1 2
Failure To Adhere Or Bond 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Malposition of Device 1 1
Material Erosion 1 5
Fire 1 1
Corroded 1 1
Crack 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1885 1933
No Clinical Signs, Symptoms or Conditions 646 750
Failure of Implant 211 271
No Code Available 85 85
No Known Impact Or Consequence To Patient 80 80
Insufficient Information 69 372
Pain 58 58
No Consequences Or Impact To Patient 54 54
Inflammation 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
No Patient Involvement 30 30
Discomfort 24 24
Unspecified Infection 22 22
Osteopenia/ Osteoporosis 22 22
Impaired Healing 11 11
Tissue Damage 10 10
Device Embedded In Tissue or Plaque 9 9
Difficulty Chewing 7 7
Fibrosis 6 6
Osteolysis 6 6
Edema 5 5
Granuloma 5 5
Missing Value Reason 5 5
Foreign Body In Patient 4 4
Abscess 4 4
Bone Fracture(s) 3 3
Pocket Erosion 3 3
Tinnitus 3 3
Swelling/ Edema 3 3
Bruxism 2 2
Tooth Fracture 2 2
Injury 2 2
Rash 2 2
Hemorrhage/Bleeding 2 2
Headache 1 1
Purulent Discharge 1 1
Fatigue 1 1
Seizures 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Swelling 1 1
Thyroid Problems 1 1
Joint Dislocation 1 1
Sinus Perforation 1 1
Visual Impairment 1 1
Weakness 1 1
Burning Sensation 1 1
Dysphasia 1 1
Irritation 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 1 1
Palpitations 1 1
Inadequate Osseointegration 1 1
Reaction 1 1
Fungal Infection 1 1
Sensitivity of Teeth 1 1
Patient Problem/Medical Problem 1 1
Alteration In Body Temperature 1 1
Not Applicable 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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