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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 4
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 6
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 12
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 6
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
2026 236 291

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2061 2653
Unintended Movement 528 531
Positioning Failure 288 290
Separation Failure 88 92
Mechanical Problem 64 78
Failure to Osseointegrate 52 60
Use of Device Problem 51 168
Separation Problem 43 45
Connection Problem 31 126
Break 28 66
Insufficient Information 24 92
Loss of Osseointegration 23 25
Loose or Intermittent Connection 13 19
Adverse Event Without Identified Device or Use Problem 12 12
Misconnection 10 26
Material Deformation 10 12
Device Damaged by Another Device 9 9
Patient Device Interaction Problem 8 8
Osseointegration Problem 6 6
Detachment of Device or Device Component 5 5
Fitting Problem 4 6
Patient-Device Incompatibility 4 4
Device Appears to Trigger Rejection 3 3
Off-Label Use 3 3
Material Split, Cut or Torn 3 3
Output Problem 3 20
Component or Accessory Incompatibility 3 3
Deformation Due to Compressive Stress 3 5
Defective Device 3 3
Material Separation 3 4
Manufacturing, Packaging or Shipping Problem 2 5
Device Markings/Labelling Problem 2 2
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 10
Inadequacy of Device Shape and/or Size 2 2
Wrong Label 2 2
Difficult to Insert 2 2
Degraded 2 2
Crack 2 2
Product Quality Problem 2 3
Device Misassembled During Manufacturing /Shipping 1 1
Inadequate User Interface 1 2
Compatibility Problem 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 4
Component Missing 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2360 2524
Failure of Implant 441 529
Insufficient Information 344 956
Pain 102 103
Inflammation 60 62
No Information 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 39
Discomfort 31 31
Unspecified Infection 25 26
Swelling/ Edema 22 22
Osteolysis 19 19
Fungal Infection 12 12
Osteopenia/ Osteoporosis 12 12
Implant Pain 9 9
Pocket Erosion 8 12
Impaired Healing 7 7
No Consequences Or Impact To Patient 7 7
No Code Available 6 6
Inadequate Osseointegration 6 6
Burning Sensation 6 6
Hypersensitivity/Allergic reaction 5 5
Abscess 5 5
Bruxism 4 4
Fibrosis 4 4
Granuloma 4 4
Foreign Body In Patient 2 2
Dyspnea 2 2
Physical Asymmetry 2 2
Hemorrhage/Bleeding 2 2
Headache 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
Loss of Range of Motion 1 1
Numbness 1 2
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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