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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, endosseous, root-form
Regulation Description Endosseous dental implant.
Product CodeDZE
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
ABRACADABRA IMPLANTS LTD
  SUBSTANTIALLY EQUIVALENT 1
ADIN DENTAL IMPLANT SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ADIN DENTAL IMPLANTS SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALPHA DENT IMPLANTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
ALTATEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 1
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ARUMDENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
  SUBSTANTIALLY EQUIVALENT 2
B.T.I. BIOTECHNOLOGY INSTITUTE, SL
  SUBSTANTIALLY EQUIVALENT 1
BEGO IMPLANT SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIO CONCEPT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
BIOHORIZONS IMPLANT SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET 3I LLC
  SUBSTANTIALLY EQUIVALENT 2
BIOMET 3I, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH DENTAL LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH DENTAL, SAS
  SUBSTANTIALLY EQUIVALENT 2
BIOTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BLUE SKY BIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CYBERMED INC.
  SUBSTANTIALLY EQUIVALENT 1
D.S.P INDUSTRIAL EIRELI
  SUBSTANTIALLY EQUIVALENT 1
DENQ
  SUBSTANTIALLY EQUIVALENT 1
DENTAL EVOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
DENTIUM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DITRON DENTAL LTD
  SUBSTANTIALLY EQUIVALENT 2
DSI DENTAL SOLUTIONS LTD
  SUBSTANTIALLY EQUIVALENT 1
EBI INC.
  SUBSTANTIALLY EQUIVALENT 1
F&B TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GUILIN FITEETH MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU MINSHENG LIDE MEDICAL SCIENCE & TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HIGHNESS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOOWON EDI CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
I DO BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
IDIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT DIRECT SYBRON MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTS DIFFUSION INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
INFINITUM ETA LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOBIOSURG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 8
IVORY SUPER HOLDCO INC. / ZEST ANCHORS LLC
  SUBSTANTIALLY EQUIVALENT 1
IZENIMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
J DENTAL CARE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
JDENTALCARE SRL
  SUBSTANTIALLY EQUIVALENT 2
JIANGYIN JINTECH BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JJ MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 7
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS SA
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 3
KJ MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIKA GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDENTIS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INSTINCT DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMECCA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
MOZO GRAU S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEWTON IMPLANT SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
NEWTON IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AG
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 1
NORIS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
NORIS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVODENT SA
  SUBSTANTIALLY EQUIVALENT 1
ONEDAY BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSVIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PALTOP ADVANCED DENTAL SOLUTIONS, LTD
  SUBSTANTIALLY EQUIVALENT 3
POINTNIX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
QRS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUADRIC BIOMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUICKDENT DEVICES PRIVATE LTD.
  SUBSTANTIALLY EQUIVALENT 1
RDJ TOV IMPLANT LTD
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 5
S.I.N. -SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N.- SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N.-SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SANLILAR TIBBI CIHAZLAR MEDIKAL KIMYA SANAYI TICARET LTD. ST
  SUBSTANTIALLY EQUIVALENT 1
SDS SWISS DENTAL SOLUTIONS AG
  SUBSTANTIALLY EQUIVALENT 1
SEWON MEDIX INC.
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG MST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIC INVENT AG
  SUBSTANTIALLY EQUIVALENT 1
SNUCONE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 5
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUNCOAST DENTAL, INC. DBA TATUM SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTD
  SUBSTANTIALLY EQUIVALENT 1
SURGIKOR LLC
  SUBSTANTIALLY EQUIVALENT 1
T-PLUS IMPLANT TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERRATS MEDICAL SL
  SUBSTANTIALLY EQUIVALENT 1
TRATE AG
  SUBSTANTIALLY EQUIVALENT 1
TRI DENTAL IMPLANTS INT. AG
  SUBSTANTIALLY EQUIVALENT 2
TRUABUTMENT INC.
  SUBSTANTIALLY EQUIVALENT 2
UNIDENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
Z-SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 3
Z7 LLC
  SUBSTANTIALLY EQUIVALENT 1
ZENTEK MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ZEROS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 255524 246727
2021 479618 449271
2022 483224 593161
2023 537594 537685
2024 473635 697105
2025 46900 65489

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 1358099 1572943
Loss of Osseointegration 521661 586465
Osseointegration Problem 238988 238989
Adverse Event Without Identified Device or Use Problem 89492 92720
Fracture 41232 41779
Use of Device Problem 17925 17932
Difficult to Insert 8952 9003
Patient Device Interaction Problem 8692 8692
Insufficient Information 5658 5656
Separation Failure 3651 4111
Positioning Failure 3346 3340
Migration 2950 2950
Malposition of Device 2544 3037
Premature Separation 2463 2463
Material Deformation 2174 2670
Mechanical Problem 1517 1515
Positioning Problem 1362 1362
Device Markings/Labelling Problem 1195 1195
Activation, Positioning or Separation Problem 1154 1154
Difficult to Remove 638 635
Off-Label Use 502 502
Unintended Movement 412 425
Device Damaged by Another Device 398 901
Loosening of Implant Not Related to Bone-Ingrowth 345 589
Crack 337 315
Component Missing 270 270
Defective Device 245 245
Patient-Device Incompatibility 221 221
Missing Information 143 143
Unsealed Device Packaging 128 128
Detachment of Device or Device Component 119 117
Naturally Worn 101 101
Appropriate Term/Code Not Available 100 100
Device Slipped 94 94
Contamination /Decontamination Problem 86 86
Material Discolored 78 78
Flaked 75 75
Migration or Expulsion of Device 74 73
Packaging Problem 68 68
Break 67 67
Connection Problem 66 66
No Apparent Adverse Event 53 53
Separation Problem 52 52
Expulsion 45 45
Loose or Intermittent Connection 44 44
Inadequacy of Device Shape and/or Size 39 39
Corroded 35 35
Improper or Incorrect Procedure or Method 32 145
Labelling, Instructions for Use or Training Problem 31 31
Manufacturing, Packaging or Shipping Problem 31 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1372745 1441320
No Clinical Signs, Symptoms or Conditions 429436 537571
Pain 306810 328811
Unspecified Infection 244577 260174
Fibrosis 226607 269351
Inflammation 87049 91787
Insufficient Information 55765 56107
Tissue Damage 53569 52268
Swelling/ Edema 42761 45156
Hemorrhage/Bleeding 42755 44606
Numbness 33953 34003
Inadequate Osseointegration 32519 103518
Abscess 24919 25258
Fistula 23509 23709
Osteolysis 21543 34319
Increased Sensitivity 15742 16350
Pocket Erosion 11116 11116
Hypersensitivity/Allergic reaction 9028 9013
Osteopenia/ Osteoporosis 8801 9533
Sinus Perforation 6479 7343
No Code Available 4179 4178
Swelling 4171 4030
Implant Pain 4056 20038
Bone Fracture(s) 3223 3223
Granuloma 2611 2611
No Information 2403 2416
Foreign Body In Patient 1940 1940
No Known Impact Or Consequence To Patient 1747 1747
Unspecified Tissue Injury 1647 1647
No Consequences Or Impact To Patient 1480 1480
Increased Sensitivity 1206 1165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1052 1174
High Blood Pressure/ Hypertension 719 7307
Discomfort 664 663
Wound Dehiscence 611 609
Osteomyelitis 488 488
Bacterial Infection 464 11810
Bruxism 442 2987
Erosion 378 341
Impaired Healing 366 366
Edema 293 293
Nerve Damage 272 272
Purulent Discharge 147 147
Sensitivity of Teeth 145 138
Patient Problem/Medical Problem 138 138
Paresthesia 129 129
Foreign Body Reaction 88 1308
Necrosis 78 76
Organ Dehiscence 51 51
Laceration(s) 45 45

Recalls
Manufacturer Recall Class Date Posted
1 Hiossen Inc. II May-18-2023
2 Implant Direct Sybron Manufacturing LLC II Nov-03-2021
3 Implant Direct Sybron Manufacturing LLC II Feb-05-2020
4 Implant Direct Sybron Manufacturing LLC II Feb-04-2020
5 Jjgc Industria E Comercio De Materials Dentarios Sa II Nov-04-2021
6 NOBEL BIOCARE SERVICES AG II Aug-20-2020
7 Nobel Biocare II Feb-05-2025
8 Nobel Biocare II Aug-23-2022
9 Nobel Biocare Usa Llc II Feb-18-2022
10 Nobel Biocare Usa Llc II Jun-03-2020
11 Nobel Biocare Usa Llc II May-04-2020
12 Nobel Biocare Usa Llc II May-04-2020
13 Nobel Biocare Usa Llc II Feb-19-2020
14 Paltop Advanced Dental Solutions Ltd II Jan-21-2020
15 SIN SISTEMA DE IMPLANTE NACIONAL S.A II Jan-15-2025
16 Straumann USA LLC II Jan-19-2022
17 Zest Anchors LLC II Jun-24-2020
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