| Primary Device ID | 00850017524163 |
| NIH Device Record Key | a2274e4b-8ec4-4b20-b69c-ffbf341c7fae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Byte Day Alignes |
| Version Model Number | HBYTETray |
| Catalog Number | PRS-0063 |
| Company DUNS | 081010579 |
| Company Name | STRAIGHT SMILE 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-765-2327 |
| support@byteme.com | |
| Phone | 866-765-2327 |
| support@byteme.com | |
| Phone | 866-765-2327 |
| support@byteme.com | |
| Phone | 866-765-2327 |
| support@byteme.com | |
| Phone | 866-765-2327 |
| support@byteme.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017524163 [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 | 2022-06-08 |
| Device Publish Date | 2022-05-31 |
| 00850017524200 - Brightbyte Pro (wireless) Whitening Kit | 2023-09-15 [Wireless] LED teeth whitening kit |
| 00850017524224 - Portable UV Sanitizer | 2023-03-28 Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes) |
| 00850017524064 - BrightByte | 2022-10-10 A liquid cleansing agent used to remove small debris from plastic aligners |
| 00850017524088 - Brightbyte Pro Whitening Kit | 2022-06-14 LED teeth whitening kit |
| 00850017524118 - Brightbyte Pro Refill Pens | 2022-06-14 Whitening and Desensitizing Gel Pens |
| 00850017524002 - Smile Stretcher | 2022-06-10 Device to retract the lips/cheeks to facilitate viewing of the teeth. |
| 00850017524019 - Impression Kit Standard | 2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit |
| 00850017524033 - Impression Rekit (Small) | 2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit |