ClearCorrect System REF-03

GUDID D865REF00031

The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner

Clearcorrect Operating, LLC

Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable
Primary Device IDD865REF00031
NIH Device Record Key134b8975-68af-47c9-8f99-002a2b75e4dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearCorrect System
Version Model NumberAligner (Multi-layer)
Catalog NumberREF-03
Company DUNS016449078
Company NameClearcorrect Operating, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com
Phone888-331-3323
Emailsupport@clearcorrect.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]
HIBCCD865REF00031 [Primary]

FDA Product Code

NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential
NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [ClearCorrect System]

D865REF0001The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ
D865REF00051The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a seque
D865REF00041The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic a
D865REF00031The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite
D865REF00021Engager template device accessory for use with the ClearCorrect System.
D865REF00011The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ

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