Inman Digital Clear Aligner

GUDID D141DCA2532729

Inman Digital Clear Aligner

Inman Orthodontic Laboratories, Inc.

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Primary Device IDD141DCA2532729
NIH Device Record Keyd526fcb1-1902-497a-947a-a38077a659fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameInman Digital Clear Aligner
Version Model NumberDCA253272
Company DUNS860196849
Company NameInman Orthodontic Laboratories, Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD141DCA2532729 [Package]
Contains: D141DCA253720
Package: [1 Units]
In Commercial Distribution
HIBCCD141DCA253720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

Devices Manufactured by Inman Orthodontic Laboratories, Inc.

D141DCA2532729 - Inman Digital Clear Aligner2023-11-08Inman Digital Clear Aligner
D141DCA2532729 - Inman Digital Clear Aligner2023-11-08 Inman Digital Clear Aligner
D141IPC9 - Inman Power Component2023-11-07 Inman Power Component
DCA253272 - Inman Digital Clear Aligners2023-10-04 Clear plastic sequential orthodontic tooth aligners. Clear plastic trays that fit over the upper or lower teeth to create correc

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