| Primary Device ID | 00850007728014 |
| NIH Device Record Key | 65a30ba5-da48-4602-8283-ef91a57251bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIDCOURSE CORRECTIONS KIT |
| Version Model Number | 100-0010 |
| Company DUNS | 054012763 |
| Company Name | ACCESS DENTAL LAB, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00850007728014 [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 | 2019-06-14 |
| Device Publish Date | 2019-06-06 |
| 00850007728427 - SmileDirectClub Retainer | 2023-12-08 SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in the |
| 00850007728243 - SDC impression material (Zest) | 2023-02-27 impression material used to create dental impressions |
| 00850007728250 - SDC-impression material (Kulzer) | 2023-02-27 putty material used to create dental impressions. |
| 00850007728342 - Smile stretcher-purple bag | 2023-02-27 Smile stretcher in foil purple pouch |
| 00850007728366 - Impression Tray XSM | 2023-02-27 Impression Tray Extra Small |
| 00850007728373 - IMPRESSION TRAY SM | 2023-02-27 IMPRESSION TRAY SMALL SIZE |
| 00850007728380 - IMPRESSION TRAY MED | 2023-02-27 IMPRESSION TRAY MEDIUM SIZE |
| 00850007728397 - IMPRESSION TRAY LRG | 2023-02-27 IMPRESSION TRAY LARGE SIZE |