Straight Smile, LLC
FDA Regulatory Profile
Straight Smile, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0750-2025, Class II) was initiated on November 4, 2024. Its most recent 510(k) clearance was granted on February 19, 2019.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0750-2025 | Class II | BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A c | November 4, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180346 | Byte Aligner System | February 19, 2019 |