Byte Aligner System
510(k) K180346
Byte Aligner System is a medical device (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Straight Smile LLC, cleared under FDA 510(k) K180346 on 19 Feb 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180346 | Date19 Feb 2019 | StatusActive |
Official records
- FDA 510(k) database K180346
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXC
- FDA applicant
- Straight Smile, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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