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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aligner, sequential
Regulation Description Orthodontic plastic bracket.
Definition The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Product CodeNXC
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
3D GLOBAL BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY, UNITEK ORTHODONTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALIEN MILLING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ALIGN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 8
ARKLIGN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ASO INTERNATIONAL MANILA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEAME MEDICAL TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH DENTAL SMILERS, SAS
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC
  SUBSTANTIALLY EQUIVALENT 2
BRIUS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CDB CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLEAR MOVES ALIGNERS
  SUBSTANTIALLY EQUIVALENT 1
CLEARCORRECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLEARPATH ORTHODONTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREODENT PROSTHETICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRISTALINE ALIGNERS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTCARE DENTAL LAB PVT , LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
ENSMILE PVT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENIOVA TECHNOLOGIES SOCIEDAD LIMITADA
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY, INC.
  SUBSTANTIALLY EQUIVALENT 2
GRUPPO EUROPEO ORTODONZIA SRL
  SUBSTANTIALLY EQUIVALENT 1
INMAN ORTHODONTIC LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNS DENTAL LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
KEY DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
KLINE EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LAXMI DENTAL EXPORT PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAXMI DENTAL EXPORTS PVT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUXCREO, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAKEO HEALTHCARE TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEM DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MODERN DENTAL LABORATORY (DG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING JIAHE DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEW ENGLAND ORTHO LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OHLENDORF APPLIANCE LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORAL IMAGE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORDONT ORTHODONTIC LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ORTHO LAB SERVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARK DENTAL RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PEARL DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERFECTION ALIGNER SYSTEM HONG KONG LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRECISION ALIGN, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MEIMING DENTISTRY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YINUO DENTAL TECHNOLOGY CO.LTD
  SUBSTANTIALLY EQUIVALENT 1
SMS OPCO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMYLIO, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPACE MAINTAINERS LABORATORIES (SML)
  SUBSTANTIALLY EQUIVALENT 1
STR8 ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
TNS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULAB SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS AND SERVICES
  SUBSTANTIALLY EQUIVALENT 1
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED.
  SUBSTANTIALLY EQUIVALENT 2
XPLORA 3D EUROPE S.L
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 929 931
2022 605 609
2023 433 433
2024 8991 8993
2025 4578 4578

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 9532 9535
Sharp Edges 2744 2744
Adverse Event Without Identified Device or Use Problem 1800 1800
Inadequacy of Device Shape and/or Size 1153 1153
Device Appears to Trigger Rejection 449 449
Lack of Effect 419 419
Structural Problem 414 414
Unintended Movement 322 322
Appropriate Term/Code Not Available 150 151
Patient Device Interaction Problem 129 129
Insufficient Information 79 79
Crack 64 64
Break 55 55
Pressure Problem 44 44
Fitting Problem 33 33
Biocompatibility 15 15
Therapeutic or Diagnostic Output Failure 12 12
Product Quality Problem 8 8
Improper or Incorrect Procedure or Method 6 6
Failure to Align 6 6
Material Fragmentation 6 6
Unexpected Therapeutic Results 5 5
Use of Device Problem 4 4
Material Integrity Problem 4 4
Mechanical Problem 4 4
Failure to Osseointegrate 3 3
Difficult to Remove 3 3
Increase in Pressure 3 3
Nonstandard Device 2 2
Compatibility Problem 2 2
Fail-Safe Problem 1 1
Contamination 1 1
Defective Device 1 1
Material Erosion 1 1
Infusion or Flow Problem 1 1
False Alarm 1 1
Use of Incorrect Control/Treatment Settings 1 1
Off-Label Use 1 1
Output Problem 1 2
Failure to Select Signal 1 1
Fracture 1 1
Leak/Splash 1 1
Cross Reactivity 1 1
Osseointegration Problem 1 1
Device Contaminated at the User Facility 1 1
Inadequate Instructions for Non-Healthcare Professional 1 3
Inadequate Filtration Process 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 5465 5465
Tooth Fracture 3219 3219
Laceration(s) 2713 2713
Pain 1983 1983
Tissue Breakdown 1731 1731
Insufficient Information 698 698
Hypersensitivity/Allergic reaction 567 572
Sensitivity of Teeth 552 554
Discomfort 522 522
Necrosis 449 449
Bacterial Infection 447 447
Loss of Range of Motion 426 426
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 376 378
Inflammation 309 309
Unspecified Musculoskeletal problem 290 290
Hemorrhage/Bleeding 240 240
Muscular Rigidity 223 223
Unspecified Infection 219 219
Immobility of the joint 145 145
Difficulty Chewing 143 143
Increased Sensitivity 142 142
No Clinical Signs, Symptoms or Conditions 107 107
Swelling/ Edema 100 103
Post Traumatic Wound Infection 99 99
Blister 92 92
Stomatitis 86 86
Erosion 69 69
Headache 54 57
Osteopenia/ Osteoporosis 39 39
Skin Inflammation/ Irritation 37 37
Abscess 32 32
Nerve Damage 26 26
Sore Throat 24 24
Pressure Sores 23 23
Dyspnea 22 22
Fatigue 18 21
Nodule 16 16
Anaphylactic Shock 15 15
Chest Pain 14 14
Abrasion 14 14
Choking 12 13
Local Reaction 12 12
Ulcer 12 15
Nausea 11 11
Osteolysis 8 8
Arthralgia 8 11
Anxiety 8 8
Itching Sensation 8 8
Vertigo 7 7
Numbness 7 7

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-23-2024
2 Straight Smile, LLC II Dec-23-2024
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