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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
ACHIMHAI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALLONUS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET 3I LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET 3I, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC
  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 10
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 9
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 2
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ECLECTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEGANT DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELOS MEDTECH PINOL A/S
  SUBSTANTIALLY EQUIVALENT 9
EUROTEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN INC.
  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 1
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 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 13
INTEGRATED DENTAL SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
IVORY SUPER HOLDCO, INCP.
  SUBSTANTIALLY EQUIVALENT 1
IZENIMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
J & P DENTAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDÚSTRIA E COMÉRCIA DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 2
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 3
MEGAGEN IMPLANT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
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 4
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 3
OSSVIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PANTHERA DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
SMART DENTURE CONVERSIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 3
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
STRAUMANN USA, LLC (ON BEHALF OF INSTITUT STRAUMANN AG)
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPANA, SL
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 4
TECHWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 13
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 9
WARANTEC CO., LTD,
  SUBSTANTIALLY EQUIVALENT 2
ZENTEK MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZFX GMBH - A COMPANY OF ZIMVIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 458 506
2021 546 779
2022 497 670
2023 624 723
2024 638 660
2025 173 173

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1750 2203
Unintended Movement 536 536
Positioning Failure 273 273
Separation Failure 60 60
Mechanical Problem 55 62
Failure to Osseointegrate 46 49
Separation Problem 33 33
Loss of Osseointegration 29 29
Connection Problem 21 103
Adverse Event Without Identified Device or Use Problem 18 18
Use of Device Problem 13 78
Break 11 11
Failure to Advance 10 10
Material Deformation 9 9
Loose or Intermittent Connection 8 14
Device Damaged by Another Device 8 8
Device Markings/Labelling Problem 7 7
Insufficient Information 7 68
Osseointegration Problem 6 6
Detachment of Device or Device Component 5 5
Defective Device 4 4
Component or Accessory Incompatibility 3 3
Output Problem 3 20
Deformation Due to Compressive Stress 3 5
Device Appears to Trigger Rejection 3 3
Appropriate Term/Code Not Available 3 11
Missing Information 3 3
Component Misassembled 3 3
Product Quality Problem 3 4
Improper or Incorrect Procedure or Method 2 2
Component Incompatible 2 2
Inaccurate Information 2 2
Misassembled 2 2
Material Twisted/Bent 2 2
Component Missing 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 3
Positioning Problem 2 2
Material Integrity Problem 2 2
Defective Component 2 2
Wrong Label 2 2
Patient-Device Incompatibility 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Insert 1 1
Misassembled During Installation 1 1
Unintended Compatibility 1 10
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Misconnection 1 1
Therapeutic or Diagnostic Output Failure 1 4
Manufacturing, Packaging or Shipping Problem 1 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1786 1893
No Information 416 464
Failure of Implant 340 400
Insufficient Information 187 611
Pain 84 84
Inflammation 56 56
No Code Available 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
No Consequences Or Impact To Patient 32 32
Discomfort 29 29
Unspecified Infection 28 28
Swelling/ Edema 21 21
Osteopenia/ Osteoporosis 16 16
Osteolysis 15 15
Fungal Infection 12 12
Impaired Healing 9 9
Pocket Erosion 8 8
Implant Pain 8 8
No Known Impact Or Consequence To Patient 6 6
Burning Sensation 6 6
Abscess 6 6
Fibrosis 5 5
Granuloma 5 5
No Patient Involvement 4 4
Bruxism 4 4
Hypersensitivity/Allergic reaction 3 3
Foreign Body In Patient 2 2
Physical Asymmetry 2 2
Headache 2 2
Purulent Discharge 1 1
Edema 1 1
Cognitive Changes 1 1
Skin Discoloration 1 1
Irritation 1 1
Sinus Perforation 1 1
Bone Fracture(s) 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Inadequate Osseointegration 1 1
Laceration(s) 1 1
Fatigue 1 1
Electric Shock 1 1
Hemorrhage/Bleeding 1 1
Irritability 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 DDS Lab II Feb-05-2025
4 Hiossen Inc. II Mar-05-2025
5 Implant Direct Sybron Manufacturing LLC II Jun-29-2023
6 Implant Direct Sybron Manufacturing LLC II Feb-10-2020
7 Nobel Biocare Procera LLC II May-25-2021
8 Nobel Biocare Usa Llc II Jun-03-2020
9 Nobel Biocare Usa Llc II May-04-2020
10 Preat Corp II Jul-08-2024
11 Preat Corp II Mar-20-2024
12 Preat Corp II Oct-24-2023
13 Preat Corp II Mar-24-2023
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