• 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
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
ALIEN MILLING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ALIGN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
AMPA ORTHODONTICS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 1
CLEARCORRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
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
K LINE EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
KEY DENTAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LAXMI DENTAL EXPORT PVT. LTD
  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 2
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 1
SMYLIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SPACE MAINTAINERS LABORATORIES (SML)
  SUBSTANTIALLY EQUIVALENT 1
STR8 ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
STRAIGHT T, INC.
  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
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 175 175
2021 929 929
2022 605 605
2023 433 433
2024 8968 8969
2025 1261 1261

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 6687 6688
Sharp Edges 2527 2527
Adverse Event Without Identified Device or Use Problem 1672 1672
Inadequacy of Device Shape and/or Size 1118 1118
Device Appears to Trigger Rejection 432 432
Structural Problem 391 391
Lack of Effect 288 288
Unintended Movement 247 247
Appropriate Term/Code Not Available 195 195
Insufficient Information 142 142
Patient Device Interaction Problem 84 84
Crack 57 57
Pressure Problem 44 44
Break 22 22
Biocompatibility 16 16
Product Quality Problem 9 9
Therapeutic or Diagnostic Output Failure 7 7
Improper or Incorrect Procedure or Method 7 7
Failure to Align 7 7
Material Fragmentation 6 6
Fitting Problem 6 6
Unexpected Therapeutic Results 6 6
Material Integrity Problem 4 4
Use of Device Problem 3 3
Difficult to Remove 3 3
Mechanical Problem 3 3
Compatibility Problem 2 2
Increase in Pressure 2 2
Sparking 2 2
Defective Device 2 2
False Alarm 1 1
Failure to Select Signal 1 1
Off-Label Use 1 1
Nonstandard Device 1 1
Device Contaminated at the User Facility 1 1
Cross Reactivity 1 1
Fracture 1 1
Loss of or Failure to Bond 1 1
Leak/Splash 1 1
Material Erosion 1 1
Device Damaged by Another Device 1 1
Stretched 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Packaging Problem 1 1
Inadequate Filtration Process 1 1
Chemical Problem 1 1
Infusion or Flow Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 3850 3851
Tooth Fracture 2604 2604
Laceration(s) 2500 2500
Pain 1533 1533
Tissue Breakdown 1163 1163
Insufficient Information 564 564
Hypersensitivity/Allergic reaction 485 485
Discomfort 454 454
Necrosis 418 418
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 375 375
Loss of Range of Motion 330 330
Sensitivity of Teeth 299 299
Unspecified Musculoskeletal problem 270 270
Bacterial Infection 208 208
Inflammation 190 190
Hemorrhage/Bleeding 188 188
Unspecified Infection 162 162
Muscular Rigidity 138 138
Difficulty Chewing 130 130
Increased Sensitivity 103 103
Post Traumatic Wound Infection 99 99
Swelling/ Edema 93 93
No Clinical Signs, Symptoms or Conditions 93 93
Blister 72 72
Erosion 66 66
Stomatitis 66 66
Sore Throat 60 60
Immobility of the joint 56 56
Headache 55 55
Skin Inflammation/ Irritation 35 35
Reaction 31 31
Abscess 26 26
Chest Pain 25 25
Osteopenia/ Osteoporosis 24 24
Anaphylactic Shock 21 21
Pressure Sores 21 21
Fatigue 21 21
Dyspnea 20 20
No Code Available 19 19
Nerve Damage 16 16
Abrasion 14 14
Nodule 14 14
Nausea 13 13
Swelling 12 12
Local Reaction 12 12
Ulcer 11 11
Itching Sensation 11 11
Choking 10 10
Vertigo 8 8
Numbness 8 8

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