TERA HARZ
K-Number: K202846 · 2021-07-15
ApplicantGraphy, Inc.
Decision Date2021-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TERA HARZ is a medical device manufactured by Graphy, Inc.. It received FDA 510(k) clearance on 2021-07-15 under approval number K202846. 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?
TERA HARZ is a medical device that received FDA 510(k) clearance on 2021-07-15. It is manufactured by Graphy, Inc.. The 510(k) number is K202846.
When was TERA HARZ approved by the FDA?
TERA HARZ received FDA 510(k) clearance on 2021-07-15, under approval number K202846.
What company makes TERA HARZ?
TERA HARZ is manufactured by Graphy, Inc..
What is the FDA product code for TERA HARZ?
The FDA product code for TERA HARZ is EBF.
Other Devices by Graphy, Inc.
K223355Tera Harz Clear
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)
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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.