Primary Device ID | D141DCA2532729 |
NIH Device Record Key | d526fcb1-1902-497a-947a-a38077a659fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Inman Digital Clear Aligner |
Version Model Number | DCA253272 |
Company DUNS | 860196849 |
Company Name | Inman Orthodontic Laboratories, Inc. |
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 | false |
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 | D141DCA2532729 [Package] Contains: D141DCA253720 Package: [1 Units] In Commercial Distribution |
HIBCC | D141DCA253720 [Primary] |
NXC | Aligner, Sequential |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-08 |
Device Publish Date | 2023-10-31 |
D141DCA2532729 - Inman Digital Clear Aligner | 2023-11-08Inman Digital Clear Aligner |
D141DCA2532729 - Inman Digital Clear Aligner | 2023-11-08 Inman Digital Clear Aligner |
D141IPC9 - Inman Power Component | 2023-11-07 Inman Power Component |
DCA253272 - Inman Digital Clear Aligners | 2023-10-04 Clear plastic sequential orthodontic tooth aligners. Clear plastic trays that fit over the upper or lower teeth to create correc |