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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 a medical device manufactured by Graphy, Inc.. It received FDA 510(k) clearance on 2023-11-01 under approval 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. It is manufactured by Graphy, Inc.. The 510(k) number is K233502.

When was TERA HARZ II approved by the FDA?

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

What company makes TERA HARZ II?

TERA HARZ II is manufactured by Graphy, Inc..

What is the FDA product code for TERA HARZ II?

The FDA product code for TERA HARZ II is EBF.

Other Devices by Graphy, Inc.

K202846TERA HARZ K223355Tera Harz Clear K222414TERA HARZ DENTURE K240597TERA HARZ CLEAR 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)

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K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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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