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FDA 510(k)

DigiLine Direct Print Aligner System

K-Number: K233935 · 2024-04-05

ApplicantPark Dental Research Corporation
Decision Date2024-04-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DigiLine Direct Print Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corporation. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233935. 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 DigiLine Direct Print Aligner System?

DigiLine Direct Print Aligner System is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Park Dental Research Corporation. The 510(k) number is K233935.

When did DigiLine Direct Print Aligner System receive FDA 510(k) clearance?

DigiLine Direct Print Aligner System received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233935.

Who is the listed applicant for DigiLine Direct Print Aligner System?

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

What is the FDA product code for DigiLine Direct Print Aligner System?

The FDA product code for DigiLine Direct Print Aligner System is NXC.

Other records listing Park Dental Research Corporation as applicant

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.

K252976Park Dental Nylon MADK180648Park Dental Research AlignersK181220Juell 3D Volo Base

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.

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