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FDA 510(k)

TERA HARZ II

K-Number: K233502 · 2023-11-01

ApplicantGraphy, Inc.
Decision Date2023-11-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TERA HARZ II is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2023-11-01 under 510(k) number K233502. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERA HARZ II?

TERA HARZ II is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Graphy, Inc.. The 510(k) number is K233502.

When did TERA HARZ II receive FDA 510(k) clearance?

TERA HARZ II received FDA 510(k) clearance on 2023-11-01, under 510(k) number K233502.

Who is the listed applicant for TERA HARZ II?

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 II?

The FDA product code for TERA HARZ II is EBF.

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 CLEARK223355Tera Harz ClearK222414TERA HARZ DENTUREK202846TERA HARZ

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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