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 a medical device manufactured by Graphy, Inc.. It received FDA 510(k) clearance on 2022-11-03 under approval 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. It is manufactured by Graphy, Inc.. The 510(k) number is K223355.
When was Tera Harz Clear approved by the FDA?
Tera Harz Clear received FDA 510(k) clearance on 2022-11-03, under approval number K223355.
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.
K202846TERA HARZ
K222414TERA HARZ DENTURE
K233502TERA HARZ II
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)
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.