Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device aligner, sequential
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 GLOBAL BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
3D SMILE USA, INC
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY, UNITEK ORTHODONTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
ALIGN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
AMPA ORTHODONTICS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ARCADLAB
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 2
CLEARCORRECT LLC
  SUBSTANTIALLY EQUIVALENT 1
CLEARCORRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLEARPATH ORTHODONTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
CREODENT PROSTHETICS LTD
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDINGS, LLC
  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
DROR ORTHODESIGN
  SUBSTANTIALLY EQUIVALENT 1
DYNAFLEX
  SUBSTANTIALLY EQUIVALENT 1
ENSMILE PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
EON DENTAL JORDAN LLC
  SUBSTANTIALLY EQUIVALENT 1
FIVE STAR ORTHODONTIC LAB & SUPPLY
  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
K LINE EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
KEY DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LAXMI DENTAL EXPORTS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
LUXCREO INC
  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 1
NEW ENGLAND ORTHO LAB, INC.
  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 1
ORTHO LAB SERVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHODENT LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSW MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
PARK DENTAL RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PERFECTION ALIGNER SYSTEM HONG KONG LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRECISION ALIGN LLC.
  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
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 1
SMYLIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SPACE MAINTAINERS LABORATORIES (SML)
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY APPLIANCE WORKS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STR8 ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
STRAIGHT SMILE, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAIGHT T, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUN DENTAL LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
TNS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
VOODOO MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 127 127
2020 175 175
2021 929 929
2022 605 605
2023 433 433
2024 242 242

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1598 1598
Inadequacy of Device Shape and/or Size 305 305
Appropriate Term/Code Not Available 235 235
Patient-Device Incompatibility 190 190
Insufficient Information 111 111
Device Appears to Trigger Rejection 61 61
Patient Device Interaction Problem 31 31
Biocompatibility 15 15
Unexpected Therapeutic Results 13 13
Improper or Incorrect Procedure or Method 11 11
Fitting Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Product Quality Problem 8 8
Unintended Movement 5 5
Failure to Align 5 5
Sharp Edges 5 5
Use of Device Problem 3 3
Break 2 2
Material Fragmentation 2 2
Defective Device 2 2
Sparking 2 2
Compatibility Problem 2 2
Pressure Problem 2 2
Material Integrity Problem 2 2
Output Problem 2 2
Lack of Effect 2 2
Material Too Soft/Flexible 1 1
Packaging Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Chemical Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Damaged by Another Device 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Nonstandard Device 1 1
Increase in Pressure 1 1
Off-Label Use 1 1
Fracture 1 1
Loss of or Failure to Bond 1 1
Stretched 1 1
Defective Component 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 976 976
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 348 348
Necrosis 262 262
Hypersensitivity/Allergic reaction 190 190
Deformity/ Disfigurement 175 175
Pain 133 133
Post Traumatic Wound Infection 89 89
No Code Available 52 52
Tissue Breakdown 50 50
Sore Throat 49 49
Sensitivity of Teeth 45 45
Insufficient Information 39 39
Swelling/ Edema 34 34
Reaction 34 34
Swelling 34 34
Anaphylactic Shock 27 27
Unspecified Infection 26 26
Inflammation 26 26
Headache 24 24
Chest Pain 24 24
Fatigue 16 16
Itching Sensation 12 12
Dyspnea 12 12
Local Reaction 12 12
Laceration(s) 11 11
Abrasion 10 10
Nausea 10 10
Burning Sensation 9 9
Abscess 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Increased Sensitivity 9 9
Irritation 8 8
Unspecified Musculoskeletal problem 7 7
Numbness 7 7
No Known Impact Or Consequence To Patient 6 6
Dizziness 6 6
Ulcer 6 6
Pressure Sores 6 6
Anxiety 6 6
Discomfort 6 6
Rash 6 6
Therapeutic Effects, Unexpected 6 6
Vertigo 6 6
Tachycardia 4 4
Abdominal Pain 4 4
Erythema 4 4
Weight Changes 4 4
Neck Pain 4 4
Sleep Dysfunction 4 4
Cognitive Changes 4 4
Blood Loss 4 4
Arthralgia 3 3
Choking 3 3
Swollen Lymph Nodes/Glands 3 3
Cough 3 3
Angioedema 3 3
Skin Inflammation/ Irritation 3 3
Edema 3 3
Diarrhea 3 3
Fever 3 3
Bone Fracture(s) 3 3
Hemorrhage/Bleeding 3 3
Nerve Damage 3 3
Therapeutic Response, Decreased 3 3
Cramp(s) 2 2
Subclinical Infection 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Occlusion 2 2
Skin Discoloration 2 2
Swollen Lymph Nodes 2 2
Vomiting 2 2
Ulceration 2 2
Hair Loss 2 2
Failure of Implant 2 2
Memory Loss/Impairment 2 2
Dysphagia/ Odynophagia 2 2
Bacterial Infection 2 2
Blister 2 2
Dry Mouth 2 2
Balance Problems 2 2
Convulsion/Seizure 2 2
Speech Disorder 2 2
Unspecified Nervous System Problem 2 2
Difficulty Chewing 2 2
Patient Problem/Medical Problem 2 2
Constipation 1 1
Foreign Body In Patient 1 1
Suicidal Ideation 1 1
Partial Hearing Loss 1 1
Pancreatitis 1 1
Nasal Obstruction 1 1
Palpitations 1 1
Skin Tears 1 1
Polydipsia 1 1
Confusion/ Disorientation 1 1
Abdominal Cramps 1 1
Skin Inflammation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Difficulty Chewing 1 1

-
-