Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Precision Align

K-Number: K212772 · 2022-01-15

ApplicantPrecision Align, LLC
Decision Date2022-01-15
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Precision Align is the device name listed in this FDA 510(k) record. The listed applicant is Precision Align, LLC. It received FDA 510(k) clearance on 2022-01-15 under 510(k) number K212772. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Align?

Precision Align is a medical device that received FDA 510(k) clearance on 2022-01-15. The listed applicant is Precision Align, LLC. The 510(k) number is K212772.

When did Precision Align receive FDA 510(k) clearance?

Precision Align received FDA 510(k) clearance on 2022-01-15, under 510(k) number K212772.

Who is the listed applicant for Precision Align?

The FDA 510(k) record lists Precision Align, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Align?

The FDA product code for Precision Align is NXC.

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑