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Concinnity Aligners

DRAKE PRECISION DENTAL LABORATORY, INC. · Model CA0000000001 · UDI-DI 00850028222003

NXC Prescription

510(k) clearances

18,531

Adverse events (1 deaths)

Recalls

Facilities

Description

The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment. Intended Use / Indications for Use: The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

Recalls

Date	Firm	Reason
2024-11-22	3M Company - Health Care Business	Attachments may not mate with the tooth as intended in the digital treatment design.
2024-11-04	Straight Smile, LLC	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 contraindicatio

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.