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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 5
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
CERAROOT SL
  SUBSTANTIALLY EQUIVALENT 1
COWELLMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CYBERMED INC.
  SUBSTANTIALLY EQUIVALENT 1
D.A.N.D. METAL INDUSTRIES NORTH LTD
  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
  1.  K192221  Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLe ...
  2.  K201553  Simply Iconic Implants
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
MBA BIOTECH 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 2
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
SYNOROSS DBA OSSEONE
  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 449270
2022 483224 593161
2023 537594 537685
2024 473634 697096
2025 152173 220787

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 1427214 1676175
Loss of Osseointegration 548999 622141
Osseointegration Problem 245591 245591
Adverse Event Without Identified Device or Use Problem 92851 97080
Fracture 43547 44301
Use of Device Problem 19693 19700
Difficult to Insert 9297 9453
Patient Device Interaction Problem 8895 8895
Insufficient Information 5783 5781
Separation Failure 3743 4208
Positioning Failure 3457 3451
Migration 3307 3307
Malposition of Device 2596 3089
Premature Separation 2486 2486
Material Deformation 2190 2686
Mechanical Problem 1567 1565
Positioning Problem 1366 1366
Device Markings/Labelling Problem 1198 1198
Activation, Positioning or Separation Problem 1154 1154
Difficult to Remove 638 635
Off-Label Use 578 578
Loosening of Implant Not Related to Bone-Ingrowth 555 799
Unintended Movement 429 442
Device Damaged by Another Device 398 901
Crack 352 330
Component Missing 281 281
Defective Device 245 245
Patient-Device Incompatibility 242 242
Missing Information 143 143
Unsealed Device Packaging 134 134
Detachment of Device or Device Component 126 124
Labelling, Instructions for Use or Training Problem 105 105
Flaked 101 101
Naturally Worn 101 101
Appropriate Term/Code Not Available 100 100
Device Slipped 94 94
Contamination /Decontamination Problem 86 86
Migration or Expulsion of Device 85 84
Material Discolored 78 78
Connection Problem 75 75
No Apparent Adverse Event 73 73
Break 72 72
Packaging Problem 72 72
Expulsion 59 59
Separation Problem 57 57
Material Integrity Problem 55 55
Inadequacy of Device Shape and/or Size 46 46
Loose or Intermittent Connection 45 45
Manufacturing, Packaging or Shipping Problem 35 34
Corroded 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1451871 1520440
No Clinical Signs, Symptoms or Conditions 444267 578310
Pain 311131 339447
Unspecified Infection 256008 276482
Fibrosis 230914 286361
Inflammation 92165 98410
Insufficient Information 62623 62965
Tissue Damage 53569 52268
Swelling/ Edema 44491 48033
Hemorrhage/Bleeding 44135 46925
Inadequate Osseointegration 35609 106608
Numbness 34284 34682
Abscess 26702 27317
Fistula 24779 25306
Osteolysis 23656 36431
Increased Sensitivity 16510 17402
Pocket Erosion 12159 12159
Hypersensitivity/Allergic reaction 9403 9504
Osteopenia/ Osteoporosis 8986 9718
Sinus Perforation 6744 7628
Implant Pain 5375 21357
No Code Available 4179 4178
Swelling 4171 4030
Bone Fracture(s) 3367 3367
Granuloma 2623 2623
No Information 2407 2420
Foreign Body In Patient 1940 1940
No Known Impact Or Consequence To Patient 1747 1747
Unspecified Tissue Injury 1663 1663
No Consequences Or Impact To Patient 1480 1480
Increased Sensitivity 1206 1165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1089 1211
High Blood Pressure/ Hypertension 782 7370
Discomfort 697 696
Wound Dehiscence 615 613
Osteomyelitis 529 529
Bacterial Infection 510 11856
Erosion 490 453
Bruxism 463 3008
Impaired Healing 367 367
Nerve Damage 311 311
Edema 293 293
Purulent Discharge 160 160
Paresthesia 149 149
Sensitivity of Teeth 146 139
Patient Problem/Medical Problem 138 138
Foreign Body Reaction 95 1315
Necrosis 86 84
Organ Dehiscence 51 51
Laceration(s) 51 51

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 May-28-2025
17 Straumann USA LLC II Jan-19-2022
18 Zest Anchors LLC II Jun-24-2020
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