FDA 510(k)

Redline

K-Number: K213297 · 2022-02-09

Decision Date2022-02-09

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Redline is the device name listed in this FDA 510(k) record. The listed applicant is Johns Dental Laboratories. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K213297. 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 Redline?

Redline is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Johns Dental Laboratories. The 510(k) number is K213297.

When did Redline receive FDA 510(k) clearance?

Redline received FDA 510(k) clearance on 2022-02-09, under 510(k) number K213297.

Who is the listed applicant for Redline?

The FDA 510(k) record lists Johns Dental Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Redline?

The FDA product code for Redline 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) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

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