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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
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B.T.I. BIOTECHNOLOGY INSTITUTE, SL.
  SUBSTANTIALLY EQUIVALENT 1
BIOCLEAN DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTALPOINT AG
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 9
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 3
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ELEGANT DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELOS MEDTECH PINOL A/S
  SUBSTANTIALLY EQUIVALENT 7
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN INC.
  SUBSTANTIALLY EQUIVALENT 2
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 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 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 1
KEYSTONE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 3
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 4
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 2
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 3
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
RHEIN'83 SRL
  SUBSTANTIALLY EQUIVALENT 1
RODO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
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
SWEDEN & MARTINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPANA, SL
  SUBSTANTIALLY EQUIVALENT 2
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 9
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 9
WARANTEC CO., LTD,
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 591 591
2019 530 530
2020 458 506
2021 547 780
2022 519 692
2023 212 246

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1569 1936
Unintended Movement 454 454
Positioning Failure 226 226
Migration or Expulsion of Device 115 115
Failure to Advance 69 69
Separation Failure 60 60
Mechanical Problem 57 61
Break 49 49
Failure to Osseointegrate 46 49
Positioning Problem 32 32
Loss of Osseointegration 30 30
Adverse Event Without Identified Device or Use Problem 22 22
Connection Problem 18 99
Manufacturing, Packaging or Shipping Problem 16 19
Inaccurate Information 13 13
Use of Device Problem 13 78
Detachment of Device or Device Component 12 12
Osseointegration Problem 10 10
Component Misassembled 10 10
Device Markings/Labelling Problem 9 9
Patient-Device Incompatibility 8 8
Loose or Intermittent Connection 8 14
Unsealed Device Packaging 7 7
Device Damaged by Another Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 7
Separation Problem 5 5
Component or Accessory Incompatibility 4 4
Appropriate Term/Code Not Available 4 12
Material Deformation 4 4
Output Problem 3 20
Insufficient Information 3 64
Missing Information 3 3
Product Quality Problem 3 4
Component Missing 3 3
Defective Device 3 3
Deformation Due to Compressive Stress 2 2
Contamination /Decontamination Problem 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Misassembled 2 2
Component Incompatible 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Naturally Worn 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 4
Device Contamination with Chemical or Other Material 1 1
Unintended Compatibility 1 10
Misassembled During Installation 1 1
Material Split, Cut or Torn 1 1
Unintended Electrical Shock 1 1
Incomplete or Inadequate Connection 1 1
Crack 1 1
Detachment Of Device Component 1 1
Material Erosion 1 5
Fire 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misconnection 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Failure To Adhere Or Bond 1 1
Melted 1 1
Fitting Problem 1 2
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1373 1421
No Clinical Signs, Symptoms or Conditions 901 1008
Failure of Implant 234 294
Insufficient Information 99 436
Pain 59 59
No Code Available 57 57
No Consequences Or Impact To Patient 54 54
Inflammation 52 52
No Known Impact Or Consequence To Patient 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
No Patient Involvement 26 26
Osteopenia/ Osteoporosis 22 22
Discomfort 22 22
Unspecified Infection 22 22
Impaired Healing 11 11
Tissue Damage 10 10
Osteolysis 8 8
Fibrosis 7 7
Pocket Erosion 6 6
Granuloma 5 5
Missing Value Reason 5 5
Abscess 4 4
Device Embedded In Tissue or Plaque 3 3
Tinnitus 3 3
Swelling/ Edema 3 3
Foreign Body In Patient 2 2
Bruxism 2 2
Edema 2 2
Difficulty Chewing 2 2
Alteration In Body Temperature 1 1
Inadequate Osseointegration 1 1
Fungal Infection 1 1
Sensitivity of Teeth 1 1
Palpitations 1 1
Electric Shock 1 1
Sinus Perforation 1 1
Visual Impairment 1 1
Weakness 1 1
Burning Sensation 1 1
Dysphasia 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Purulent Discharge 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Rash 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Thyroid Problems 1 1
Irritation 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 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 Keystone Dental Inc II Feb-14-2018
8 Nobel Biocare Procera LLC II May-25-2021
9 Nobel Biocare Usa Llc II Jun-03-2020
10 Nobel Biocare Usa Llc II May-04-2020
11 Nobel Biocare Usa Llc II Jul-23-2018
12 Preat Corp II Mar-24-2023
13 Southern Implants, (Pty.) Ltd. II Apr-16-2018
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