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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 DIAGNOSTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
3D GLOBAL BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
3D SMILE USA, 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
ARCADLAB
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARKLIGN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ASO INTERNATIONAL MANILA, INC.
  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
DRAKE PRECISION DENTAL LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
DROR ORTHODESIGN
  SUBSTANTIALLY EQUIVALENT 1
ENSMILE PVT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EON DENTAL JORDAN, LLC
  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
MOTOR CITY LAB WORKS
  SUBSTANTIALLY EQUIVALENT 1
MVP ALIGNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANJING JIAHE DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEW ENGLAND ORTHO LAB, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
ROYAL DENTAL LAB
  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
STRAIGHT T, INC.
  SUBSTANTIALLY EQUIVALENT 1
TNS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TP ORTHODONTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULAB SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSAL ORTHODONTIC LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS AND SERVICES
  SUBSTANTIALLY EQUIVALENT 1
VITANG TECHNOLOGY, LLC
  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
2020 175 179
2021 929 931
2022 605 609
2023 433 433
2024 8974 8976
2025 4379 4379

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 9382 9386
Sharp Edges 2726 2726
Adverse Event Without Identified Device or Use Problem 1793 1793
Inadequacy of Device Shape and/or Size 1156 1156
Device Appears to Trigger Rejection 448 448
Lack of Effect 416 416
Structural Problem 411 411
Unintended Movement 316 316
Appropriate Term/Code Not Available 197 198
Insufficient Information 152 152
Patient Device Interaction Problem 123 123
Crack 61 61
Break 55 55
Pressure Problem 44 44
Fitting Problem 36 36
Biocompatibility 16 16
Therapeutic or Diagnostic Output Failure 13 13
Product Quality Problem 11 12
Failure to Align 10 10
Improper or Incorrect Procedure or Method 9 9
Unexpected Therapeutic Results 6 6
Material Fragmentation 6 6
Material Integrity Problem 5 5
Use of Device Problem 4 4
Mechanical Problem 4 4
Difficult to Remove 3 3
Failure to Osseointegrate 3 3
Defective Device 3 4
Increase in Pressure 3 3
Nonstandard Device 2 2
Compatibility Problem 2 2
Sparking 2 2
Contamination 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Stretched 1 3
Device Misassembled During Manufacturing /Shipping 1 1
Fail-Safe Problem 1 1
Component Missing 1 1
Material Erosion 1 1
Off-Label Use 1 1
Output Problem 1 2
Device Damaged by Another Device 1 1
Infusion or Flow Problem 1 1
False Alarm 1 1
Use of Incorrect Control/Treatment Settings 1 1
Packaging Problem 1 1
Chemical Problem 1 1
Failure to Select Signal 1 1
Leak/Splash 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 5362 5362
Tooth Fracture 3182 3182
Laceration(s) 2695 2695
Pain 1990 1992
Tissue Breakdown 1725 1725
Insufficient Information 700 700
Hypersensitivity/Allergic reaction 575 580
Sensitivity of Teeth 532 534
Discomfort 517 517
Necrosis 448 448
Bacterial Infection 424 424
Loss of Range of Motion 410 410
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 387 391
Inflammation 294 294
Unspecified Musculoskeletal problem 290 290
Hemorrhage/Bleeding 239 241
Unspecified Infection 224 224
Muscular Rigidity 209 209
Difficulty Chewing 143 143
Increased Sensitivity 141 141
Immobility of the joint 130 130
No Clinical Signs, Symptoms or Conditions 106 106
Swelling/ Edema 103 106
Post Traumatic Wound Infection 99 99
Blister 91 91
Stomatitis 85 85
Erosion 69 69
Sore Throat 65 65
Headache 58 61
Osteopenia/ Osteoporosis 38 38
Skin Inflammation/ Irritation 37 37
Abscess 32 32
Reaction 31 31
Pressure Sores 27 27
Nerve Damage 26 26
Dyspnea 25 25
Chest Pain 25 25
Fatigue 22 25
Anaphylactic Shock 21 21
No Code Available 19 20
Nodule 16 16
Nausea 15 15
Abrasion 15 15
Ulcer 14 17
Choking 12 13
Itching Sensation 12 12
Local Reaction 12 12
Swelling 12 12
Anxiety 9 9
Burning Sensation 8 10

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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