TERA HARZ CLEAR
K-Number: K240597 · 2024-03-05
ApplicantGraphy, Inc.
Decision Date2024-03-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TERA HARZ CLEAR is a medical device manufactured by Graphy, Inc.. It received FDA 510(k) clearance on 2024-03-05 under approval number K240597. 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 2024-03-05. It is manufactured by Graphy, Inc.. The 510(k) number is K240597.
When was TERA HARZ CLEAR approved by the FDA?
TERA HARZ CLEAR received FDA 510(k) clearance on 2024-03-05, under approval number K240597.
What company makes TERA HARZ CLEAR?
TERA HARZ CLEAR is manufactured by Graphy, Inc..
What is the FDA product code for TERA HARZ CLEAR?
The FDA product code for TERA HARZ CLEAR is NXC.
Other Devices by Graphy, Inc.
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K223355Tera Harz Clear
K222414TERA HARZ DENTURE
K233502TERA HARZ II
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)
Related Devices (Code: NXC)
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.