Recall Z-0750-2025— Straight Smile, LLC
Class II · Ongoing
Class II FDA medical device recall by Straight Smile, LLC, initiated 2024-11-04. It names one FDA 510(k) clearance: K230199. Product: BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.. Reason: Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications..
- Recalling firm
- Straight Smile, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-04
- Firm location
- Lehi, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Reason for recall
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.