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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
AVINENT IMPLANT SYSTEM S.L.U.
  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 2
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
DROR ORTHODESIGN , LTD.
  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 3
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
2026 2303 2303

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 9891 9892
Sharp Edges 4476 4476
Device Appears to Trigger Rejection 2124 2124
Adverse Event Without Identified Device or Use Problem 1851 1851
Defective Device 1676 1676
Inadequacy of Device Shape and/or Size 1154 1154
Lack of Effect 417 417
Structural Problem 414 414
Unintended Movement 380 380
Appropriate Device Problem Term/Code Not Available 151 152
Patient Device Interaction Problem 148 148
Insufficient Device Problem Information 78 78
Crack 63 63
Break 54 54
Pressure Problem 44 44
Fitting Problem 32 32
Biocompatibility 15 15
Material Fragmentation 6 6
Therapeutic or Diagnostic Output Failure 4 4
Difficult to Remove 4 4
Failure to Align 3 3
Increase in Pressure 3 3
Failure to Osseointegrate 3 3
Mechanical Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Material Integrity Problem 3 3
Product Quality Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Nonstandard Device 1 1
Contamination 1 1
Inadequate Filtration Process 1 1
False Alarm 1 1
Cross Reactivity 1 1
Infusion or Flow Problem 1 1
Material Erosion 1 1
Leak/Splash 1 1
Device Contaminated at the User Facility 1 1
Failure to Select Signal 1 1
Application Program Freezes or Fails to Launch 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 7317 7317
Tooth Fracture 5024 5024
Laceration(s) 4447 4447
Hypersensitivity/Allergic reaction 2259 2264
Tooth Loss 2243 2244
Necrosis 2125 2125
Pain 2107 2107
Tissue Breakdown 1810 1810
Swelling/ Edema 1780 1783
Abscess 1709 1709
Insufficient Information 699 699
Sensitivity of Teeth 626 628
Discomfort 580 580
Bacterial Infection 494 494
Loss of Range of Motion 441 441
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 386 388
Inflammation 318 318
Unspecified Musculoskeletal problem 317 317
Hemorrhage/Blood Loss/Bleeding 253 253
Muscular Rigidity 231 231
Unspecified Infection 228 228
Joint locking 167 167
Difficulty Chewing 154 154
Hyperresponsive to stimuli 143 143
Stomatitis 116 116
No Clinical Signs, Symptoms or Conditions 113 113
Blister 100 100
Wound Infection 99 99
Erosion 69 69
Tissue Irritation 59 59
Headache 55 58
Osteopenia/ Osteoporosis 39 39
Skin Inflammation/ Irritation 38 38
Nerve Damage 26 26
Sore Throat 24 24
Dyspnea 23 23
Pressure Sore/Ulcer 23 23
Fatigue 18 21
Anaphylactic Shock 17 17
Nodule 17 17
Ulcer 16 19
Abrasion 15 15
Chest Pain 14 14
Choking 12 13
Local Reaction 12 12
Nausea 11 11
Itching Sensation 8 8
Anxiety 8 8
Osteolysis 8 8
Arthralgia 8 11

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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