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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
ADIN DENTAL IMPLANT SYSTEMS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALLONUS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
B.T.I. BIOTECHNOLOGY INSTITUTE, SL.
  SUBSTANTIALLY EQUIVALENT 3
BIOCLEAN DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET 3I, LLC
  SUBSTANTIALLY EQUIVALENT 2
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 9
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ECLECTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELOS MEDTECH PINOL A/S
  SUBSTANTIALLY EQUIVALENT 7
EUROTEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEOMEDI CO,., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMAGINE MILLING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT LOGISTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT PROTESIS DENTAL 2004, S.L.
  SUBSTANTIALLY EQUIVALENT 5
IMPLANT SOLUTIONS PTY LTD (AKA OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT SOLUTIONS PTY LTD (OSTEON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
INFINITUM ETA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOBIOSURG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE PRODUCT BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 11
INTEGRATED DENTAL SYSTEMS, LLC
  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 2
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 3
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 3
KEYSTONE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 3
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
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 SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
NORIS MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ONEDAY BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPEN IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ORANGECAD MED GMBH
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OSSVIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PREAT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 5
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. IMPLANT SYSTEM LTDA
  SUBSTANTIALLY EQUIVALENT 1
SEUM MEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG MST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMDA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMART DENTURE CONVERSIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY), LTD.
  SUBSTANTIALLY EQUIVALENT 2
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPANA, SL
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 5
TECHWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 16
TRUABUTMENT, INC.
  SUBSTANTIALLY EQUIVALENT 7
WARANTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZENTEK MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 6
ZFX GMBH - A COMPANY OF ZIMVIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 546 790
2022 497 709
2023 618 747
2024 636 663
2025 850 982

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1915 2507
Unintended Movement 523 526
Positioning Failure 286 288
Separation Failure 82 86
Mechanical Problem 61 69
Failure to Osseointegrate 51 59
Separation Problem 43 45
Use of Device Problem 37 130
Connection Problem 31 126
Loss of Osseointegration 21 23
Loose or Intermittent Connection 13 19
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 11 72
Material Deformation 9 11
Device Damaged by Another Device 9 9
Osseointegration Problem 6 6
Detachment of Device or Device Component 5 5
Break 5 5
Patient-Device Incompatibility 4 4
Fitting Problem 4 6
Deformation Due to Compressive Stress 3 5
Defective Device 3 3
Device Appears to Trigger Rejection 3 3
Output Problem 3 20
Material Split, Cut or Torn 3 3
Component or Accessory Incompatibility 3 3
Wrong Label 2 2
Manufacturing, Packaging or Shipping Problem 2 5
Device Markings/Labelling Problem 2 2
Patient Device Interaction Problem 2 2
Crack 2 2
Degraded 2 2
Appropriate Term/Code Not Available 2 10
Off-Label Use 2 2
Material Twisted/Bent 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 3
Improper or Incorrect Procedure or Method 1 2
Component Incompatible 1 1
Nonstandard Device 1 1
Melted 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Inadequate User Interface 1 2
Labelling, Instructions for Use or Training Problem 1 2
Misassembled 1 1
Unintended Compatibility 1 10
Component Missing 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2227 2391
Failure of Implant 404 492
Insufficient Information 284 841
Pain 98 99
Inflammation 60 62
No Information 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 39
Discomfort 31 31
Unspecified Infection 24 25
Swelling/ Edema 22 22
Osteolysis 18 18
Fungal Infection 12 12
Osteopenia/ Osteoporosis 12 12
Implant Pain 8 8
Pocket Erosion 8 12
Impaired Healing 7 7
No Consequences Or Impact To Patient 7 7
No Code Available 6 6
Burning Sensation 6 6
Hypersensitivity/Allergic reaction 5 5
Abscess 5 5
Inadequate Osseointegration 4 4
Bruxism 4 4
Fibrosis 4 4
Granuloma 4 4
Foreign Body In Patient 2 2
Dyspnea 2 2
Physical Asymmetry 2 2
Headache 2 2
Hemorrhage/Bleeding 2 2
Electric Shock 1 1
Fatigue 1 1
Sinus Perforation 1 1
Purulent Discharge 1 1
Cognitive Changes 1 1
Skin Discoloration 1 1
Numbness 1 2
Loss of Range of Motion 1 1
Laceration(s) 1 1
Irritability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DDS Lab II Feb-05-2025
2 Hiossen Inc. II Mar-05-2025
3 Implant Direct Sybron Manufacturing LLC II Jun-29-2023
4 Nobel Biocare Procera LLC II May-25-2021
5 Preat Corp II Sep-03-2025
6 Preat Corp II Jul-10-2025
7 Preat Corp II Jun-18-2025
8 Preat Corp II Jul-08-2024
9 Preat Corp II Mar-20-2024
10 Preat Corp II Oct-24-2023
11 Preat Corp II Mar-24-2023
12 Prismatik Dentalcraft, Inc. II Nov-03-2025
13 Straumann USA LLC II Apr-24-2025
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