Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 HUDSON VALLEY
  SUBSTANTIALLY EQUIVALENT 1
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 8
EUROTEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEOMEDI CO,., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 13
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 4
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
SIC INVENT AG
  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 17
TRUABUTMENT, INC.
  SUBSTANTIALLY EQUIVALENT 7
WARANTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZENTEK MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 7
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 907 1030

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2571 3222
Unintended Movement 563 566
Positioning Failure 296 298
Separation Failure 104 108
Mechanical Problem 73 87
Use of Device Problem 65 213
Failure to Osseointegrate 63 71
Separation Problem 46 48
Insufficient Information 43 119
Patient Device Interaction Problem 38 38
Connection Problem 31 126
Break 28 66
Loss of Osseointegration 25 27
Adverse Event Without Identified Device or Use Problem 15 15
Loose or Intermittent Connection 14 20
Device Damaged by Another Device 13 13
Misconnection 12 30
Fitting Problem 11 14
Material Deformation 11 13
Osseointegration Problem 7 7
Detachment of Device or Device Component 6 6
Off-Label Use 4 4
Patient-Device Incompatibility 4 4
Appropriate Term/Code Not Available 4 13
Device Appears to Trigger Rejection 4 4
Product Quality Problem 3 4
Material Separation 3 4
Defective Device 3 3
Deformation Due to Compressive Stress 3 5
Output Problem 3 20
Material Split, Cut or Torn 3 3
Component or Accessory Incompatibility 3 3
Degraded 2 2
Difficult to Insert 2 2
Manufacturing, Packaging or Shipping Problem 2 5
Material Twisted/Bent 2 2
Wrong Label 2 2
Device Markings/Labelling Problem 2 2
Crack 2 2
No Apparent Adverse Event 2 3
Inadequacy of Device Shape and/or Size 2 2
Nonstandard Device 1 1
Melted 1 1
Component Incompatible 1 1
Improper or Incorrect Procedure or Method 1 2
Failure to Disconnect 1 1
Loss of or Failure to Bond 1 1
Inadequate User Interface 1 2
Labelling, Instructions for Use or Training Problem 1 2
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2807 2971
Failure of Implant 542 630
Insufficient Information 417 1097
Pain 117 118
Inflammation 78 80
No Information 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 41
Inadequate Osseointegration 35 35
Discomfort 32 32
Unspecified Infection 30 31
Swelling/ Edema 25 25
Osteolysis 24 24
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
Burning Sensation 6 6
No Code Available 6 6
Hypersensitivity/Allergic reaction 6 6
Tooth Fracture 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
Headache 2 2
Hemorrhage/Bleeding 2 2
Skin Discoloration 1 1
Cognitive Changes 1 1
Purulent Discharge 1 1
Numbness 1 2
Sinus Perforation 1 1
Loss of Range of Motion 1 1
Fatigue 1 1
Laceration(s) 1 1
Electric Shock 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-29-2026
14 Straumann USA LLC II Mar-24-2026
15 Straumann USA LLC II Apr-24-2025
-
-