ClearCorrect System REF-02

GUDID D865REF0002

Orthodontic appliance system, adjustable

Primary Device ID	D865REF0002
NIH Device Record Key	704a57ef-6b14-48f6-be77-097ac33632ad
Commercial Distribution Status	In Commercial Distribution
Brand Name	ClearCorrect System
Version Model Number	MFG-0101 1.0
Catalog Number	REF-02
Company DUNS	016449078
Company Name	Clearcorrect Operating, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D865REF0002 [Primary]

NXC	Aligner, Sequential

Steralize Prior To Use	false
Device Is Sterile	false

D865REF06001 - ClearCorrect System Engager Template	2024-02-12 Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to
D865REF02001 - ClearCorrect System	2023-09-04 Engager template device accessory for use with the ClearCorrect System.
D865REF03001 - ClearCorrect System	2023-09-04 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to
D865REF04001 - ClearCorrect System	2023-09-04 The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth i
D865REF05001 - ClearCorrect System	2023-09-04 The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively re
D865REF00011 - ClearCorrect System	2020-07-31 The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively r
D865REF00021 - ClearCorrect System	2020-07-31 Engager template device accessory for use with the ClearCorrect System.
D865REF00031 - ClearCorrect System	2020-07-31 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to