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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 2
ACHIMHAI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
  SUBSTANTIALLY EQUIVALENT 2
B.T.I. BIOTECHNOLOGY INSTITUTE, SL.
  SUBSTANTIALLY EQUIVALENT 1
BIOCLEAN DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET 3I
  SUBSTANTIALLY EQUIVALENT 1
BIOMET 3I LLC
  SUBSTANTIALLY EQUIVALENT 2
BLUE SKY BIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CORTEX DENTAL IMPLANTS INDUSTRIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTIS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 8
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 3
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ELEGANT DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELOS MEDTECH PINOL A/S
  SUBSTANTIALLY EQUIVALENT 8
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN INC.
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGINE MILLING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT DIRECT SYBRON MANUFACTURING , LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT LOGISTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT PROTESIS DENTAL 2004 S.L
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT PROTESIS DENTAL 2004 S.L.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT PROTESIS DENTAL 2004, S.L
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT SOLUTIONS PTY LTD (AKA OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT SOLUTIONS PTY LTD (OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
INNOBIOSURG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOVATIVE PRODUCT BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 16
INTEGRATED DENTAL SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 2
IVORY SUPER HOLDCO, INCP.
  SUBSTANTIALLY EQUIVALENT 1
IZENIMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
J & P DENTAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 4
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 2
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 4
MEGAGEN IMPLANT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
MIS IMPLANTS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIT GLOBAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MODERN DENTAL LABORATORY (DG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEOSS LTD
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 3
NOBEL BIOCARE AG
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
NORIS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
ONEDAY BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPEN IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
OSSVIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 4
RODO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG MST CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG MST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMDA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 4
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC (ON BEHALF OF INSTITUT STRAUMANN AG)
  SUBSTANTIALLY EQUIVALENT 1
SURGIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPANA, SL
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 3
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 11
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 8
WARANTEC CO., LTD,
  SUBSTANTIALLY EQUIVALENT 2
ZENTEK MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZFX GMBH - A COMPANY OF ZIMVIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 530 530
2020 458 506
2021 546 779
2022 497 670
2023 624 723
2024 293 315

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1705 2158
Unintended Movement 542 542
Positioning Failure 289 289
Mechanical Problem 53 60
Failure to Osseointegrate 52 55
Separation Failure 46 46
Loss of Osseointegration 33 33
Failure to Advance 24 24
Connection Problem 21 103
Adverse Event Without Identified Device or Use Problem 21 21
Separation Problem 19 19
Break 19 19
Use of Device Problem 13 78
Inaccurate Information 13 13
Osseointegration Problem 11 11
Manufacturing, Packaging or Shipping Problem 10 13
Component Misassembled 10 10
Device Markings/Labelling Problem 9 9
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 8 8
Loose or Intermittent Connection 8 14
Material Deformation 7 7
Device Damaged by Another Device 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 6
Component or Accessory Incompatibility 4 4
Defective Device 4 4
Component Missing 3 3
Deformation Due to Compressive Stress 3 5
Product Quality Problem 3 4
Device Appears to Trigger Rejection 3 3
Missing Information 3 3
Output Problem 3 20
Insufficient Information 3 64
Appropriate Term/Code Not Available 3 11
Positioning Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Improper or Incorrect Procedure or Method 2 2
Unsealed Device Packaging 2 2
Misassembled 2 2
Defective Component 2 2
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Misconnection 1 1
Nonstandard Device 1 1
Fitting Problem 1 2
Component Incompatible 1 1
Crack 1 1
Material Erosion 1 5
Fire 1 1
Melted 1 1
Labelling, Instructions for Use or Training Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 4
Patient Device Interaction Problem 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Unintended Electrical Shock 1 1
Incomplete or Inadequate Connection 1 1
Unintended Compatibility 1 10
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1397 1504
No Information 844 892
Failure of Implant 290 350
Insufficient Information 180 604
Pain 78 78
Inflammation 59 59
No Consequences Or Impact To Patient 45 45
No Code Available 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Unspecified Infection 33 33
No Known Impact Or Consequence To Patient 32 32
Osteopenia/ Osteoporosis 26 26
Discomfort 25 25
Swelling/ Edema 19 19
No Patient Involvement 18 18
Osteolysis 14 14
Fungal Infection 13 13
Impaired Healing 9 9
Fibrosis 8 8
Burning Sensation 7 7
Pocket Erosion 6 6
Implant Pain 6 6
Granuloma 5 5
Abscess 4 4
Bruxism 4 4
Difficulty Chewing 2 2
Physical Asymmetry 2 2
Foreign Body In Patient 2 2
Edema 2 2
Headache 2 2
Tinnitus 2 2
Visual Impairment 1 1
Weakness 1 1
Dysphasia 1 1
Sinus Perforation 1 1
Numbness 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Palpitations 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Purulent Discharge 1 1
Loss of Range of Motion 1 1
Rash 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Thyroid Problems 1 1
Irritation 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 1 1
Alteration In Body Temperature 1 1
Inadequate Osseointegration 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 Jun-29-2023
5 Implant Direct Sybron Manufacturing LLC II Feb-10-2020
6 Nobel Biocare Procera LLC II May-25-2021
7 Nobel Biocare Usa Llc II Jun-03-2020
8 Nobel Biocare Usa Llc II May-04-2020
9 Preat Corp II Mar-20-2024
10 Preat Corp II Oct-24-2023
11 Preat Corp II Mar-24-2023
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