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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthodontic software
Definition The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
Product CodePNN
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
3SHAPE A/S
  SUBSTANTIALLY EQUIVALENT 1
ARCHFORM, INC
  SUBSTANTIALLY EQUIVALENT 1
BRIUS TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
CDB CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHOICE BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARADVANCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLEVALIGNER LTD
  SUBSTANTIALLY EQUIVALENT 1
DIORCO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEWARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAON MEDI INC.
  SUBSTANTIALLY EQUIVALENT 1
MECHANODONTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSELECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI EA MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOFTSMILE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFTWARE NEMOTEC S.L.
  SUBSTANTIALLY EQUIVALENT 2
SWIFT HEALTH SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
ULAB SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Align Technology Inc II Jan-26-2023
2 Orchestrate Orthodontic Technologies, Inc. II Dec-06-2021
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