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FDA 510(k)

TRIOCLEAR System

K-Number: K231884 · 2023-09-01

ApplicantModern Dental Laboratory (Dg) Co., Ltd.
Decision Date2023-09-01
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIOCLEAR System is the device name listed in this FDA 510(k) record. The listed applicant is Modern Dental Laboratory (Dg) Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231884. 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 TRIOCLEAR System?

TRIOCLEAR System is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Modern Dental Laboratory (Dg) Co., Ltd.. The 510(k) number is K231884.

When did TRIOCLEAR System receive FDA 510(k) clearance?

TRIOCLEAR System received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231884.

Who is the listed applicant for TRIOCLEAR System?

The FDA 510(k) record lists Modern Dental Laboratory (Dg) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOCLEAR System?

The FDA product code for TRIOCLEAR System is NXC.

Other records listing Modern Dental Laboratory (Dg) Co., Ltd. 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.

K231210DGA Abutment

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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