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FDA 510(k)

Tera Harz Clear

K-Number: K223355 · 2022-11-03

ApplicantGraphy, Inc.
Decision Date2022-11-03
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tera Harz Clear is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K223355. 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 Tera Harz Clear?

Tera Harz Clear is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Graphy, Inc.. The 510(k) number is K223355.

When did Tera Harz Clear receive FDA 510(k) clearance?

Tera Harz Clear received FDA 510(k) clearance on 2022-11-03, under 510(k) number K223355.

Who is the listed applicant for Tera Harz Clear?

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

What is the FDA product code for Tera Harz Clear?

The FDA product code for Tera Harz Clear is NXC.

Related Clinical Trials

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.

NCT07350343The Predictability of Directly Printed Versus Thermoformed Clear AlignersENROLLING_BY_INVITATION

Other records listing Graphy, Inc. 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.

K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)K240597TERA HARZ CLEARK233502TERA HARZ IIK222414TERA HARZ DENTUREK202846TERA HARZ

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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