510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Straight Smile, LLC

Pacific Palisades, CA, US

Straight Smile, LLC appears in FDA device records in Pacific Palisades, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Straight Smile, LLC in 2019.

Clearances by year, as a table
510(k) clearance decisions for Straight Smile, LLC, by decision year
YearClearances
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K180346Byte Aligner SystemNXCSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0750-2025BYTE 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.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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain