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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
  SUBSTANTIALLY EQUIVALENT 2
3M COMPANY, UNITEK ORTHODONTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
3M UNITEK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALIGN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCADLAB
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ASO INTERNATIONAL MANILA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO LLC
  SUBSTANTIALLY EQUIVALENT 1
BRIUS TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CDB CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CLEARPATH ORTHODONTICS LTD
  SUBSTANTIALLY EQUIVALENT 2
DENMAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DERBY DENTAL LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
DIGITAL ORTHODONTIC CARE
  SUBSTANTIALLY EQUIVALENT 1
DRAKE PRECISION DENTAL LABORATORY INC
  SUBSTANTIALLY EQUIVALENT 1
DROR ORTHODESIGN
  SUBSTANTIALLY EQUIVALENT 1
DYNAFLEX
  SUBSTANTIALLY EQUIVALENT 1
EMERGO GLOBAL CONSULTING, LLC
  SUBSTANTIALLY EQUIVALENT 1
EON DENTAL JORDAN LLC
  SUBSTANTIALLY EQUIVALENT 1
FIVE STAR ORTHODONTIC LAB & SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GREAT LAKES ORTHODONTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
LAXMI DENTAL EXPORTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
MARTZ, INC
  SUBSTANTIALLY EQUIVALENT 1
MOTOR CITY LAB WORKS
  SUBSTANTIALLY EQUIVALENT 1
MVP ALIGNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEW ENGLAND ORTHO LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
NEW ENGLAND ORTHO LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHLENDORF APPLIANCE LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CAPS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORTHODENT LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSW MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARK DENTAL RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PERFECTION ALIGNER SYSTEM HONG KONG LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ROYAL DENTAL LAB
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHATKIN F.I.R.S.T. LLC
  SUBSTANTIALLY EQUIVALENT 1
SMILE DEVELOPMENT CORP
  SUBSTANTIALLY EQUIVALENT 1
SMS OPCO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMYLIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY APPLIANCE WORKS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRAIGHT SMILE, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAIGHT T, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUN DENTAL LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
TP ORTHODONTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ULAB SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSAL ORTHODONTIC LABORATORY INC
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS AND SERVICES
  SUBSTANTIALLY EQUIVALENT 1
VITANG TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOODOO MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 41 41
2017 47 47
2018 67 67
2019 127 127
2020 175 175
2021 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 221 221
Insufficient Information 85 85
Adverse Event Without Identified Device or Use Problem 61 61
Patient-Device Incompatibility 59 59
Unexpected Therapeutic Results 10 10
Improper or Incorrect Procedure or Method 10 10
Fitting Problem 9 9
Inadequacy of Device Shape and/or Size 8 8
Therapeutic or Diagnostic Output Failure 7 7
Device Operates Differently Than Expected 6 6
Failure to Align 5 5
Product Quality Problem 5 5
Material Deformation 3 3
Scratched Material 2 2
Defective Device 2 2
Sparking 2 2
Patient Device Interaction Problem 2 2
Material Too Soft/Flexible 1 1
Device Damaged by Another Device 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Output Problem 1 1
Packaging Problem 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Stretched 1 1
Use of Device Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Device Appears to Trigger Rejection 1 1
Material Erosion 1 1
Material Frayed 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling 85 85
No Code Available 80 81
Pain 74 74
Sore Throat 64 64
Reaction 44 44
Chest Pain 41 41
Anaphylactic Shock 38 38
Hypersensitivity/Allergic reaction 35 35
Sensitivity of Teeth 30 30
Headache 25 25
Itching Sensation 23 23
Tooth Fracture 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Burning Sensation 20 20
Nausea 18 18
Irritation 17 17
Rash 17 17
Inflammation 15 15
Unspecified Infection 15 15
Fatigue 14 14
Tingling 9 9
Swelling/ Edema 9 9
Discomfort 8 8
Ulcer 8 8
Pressure Sores 8 8
Numbness 8 8
Therapeutic Effects, Unexpected 7 7
Dyspnea 7 7
Injury 7 7
Dizziness 7 7
Fever 6 6
Sleep Dysfunction 6 6
No Known Impact Or Consequence To Patient 6 6
Neck Pain 5 5
Abscess 5 5
Swollen Lymph Nodes 5 5
Vomiting 5 5
Abdominal Pain 5 5
Diarrhea 5 5
Asthma 4 4
Blood Loss 4 4
Weight Changes 4 4
Cramp(s) 4 4
Abrasion 4 4
Insufficient Information 4 4
Erythema 3 3
Muscle Spasm(s) 3 3
Sneezing 3 3
Deformity/ Disfigurement 3 3
Ulceration 3 3
Choking 3 3
Edema 3 3
Hemorrhage/Bleeding 3 3
Bone Fracture(s) 3 3
Therapeutic Response, Decreased 3 3
Necrosis 3 3
Laceration(s) 3 3
Respiratory Distress 2 2
Seizures 2 2
Tachycardia 2 2
Weakness 2 2
Hair Loss 2 2
Blurred Vision 2 2
Chest Tightness/Pressure 2 2
Arthralgia 2 2
Anxiety 2 2
Difficulty Chewing 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Vertigo 2 2
Swollen Glands 2 2
Occlusion 2 2
Dysphagia/ Odynophagia 2 2
Palpitations 2 2
Cough 2 2
Abdominal Cramps 1 1
Skin Tears 1 1
Skin Inflammation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Erosion 1 1
Flatus 1 1
Gastritis 1 1
Memory Loss/Impairment 1 1
Fainting 1 1
Low Blood Pressure/ Hypotension 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Chills 1 1
Osteolysis 1 1
Toxicity 1 1
Constipation 1 1
Dry Mouth 1 1
Skin Inflammation/ Irritation 1 1
Alteration in Body Temperature 1 1
Decreased Appetite 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Depression 1 1
Disability 1 1
Inadequate Pain Relief 1 1

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