K-number	K260788
Device name	Smylio Aligners
Applicant	Smylio, Inc.
Product code	NXC
Device class	Class II
Decision date	May 8, 2026
Decision	Substantially Equivalent
Regulation	872.5470

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Smylio Aligners are orthodontic plastic brackets indicated for the alignment of teeth during orthodontic treatment of malocclusion. They are designed for prescription use in adolescents and adults.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to the Quality Management System Regulation (QMSR) including ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), 8.5.2 (Corrective action), and 8.5.3 (Preventative action).

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Smylio Aligners

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