TERA HARZ DENTURE
K-Number: K222414 · 2022-08-11
ApplicantGraphy, Inc.
Decision Date2022-08-11
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TERA HARZ DENTURE is a medical device manufactured by Graphy, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K222414. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TERA HARZ DENTURE?
TERA HARZ DENTURE is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Graphy, Inc.. The 510(k) number is K222414.
When was TERA HARZ DENTURE approved by the FDA?
TERA HARZ DENTURE received FDA 510(k) clearance on 2022-08-11, under approval number K222414.
What company makes TERA HARZ DENTURE?
TERA HARZ DENTURE is manufactured by Graphy, Inc..
What is the FDA product code for TERA HARZ DENTURE?
The FDA product code for TERA HARZ DENTURE is EBI.
Other Devices by Graphy, Inc.
K202846TERA HARZ
K223355Tera Harz Clear
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: EBI)
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K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry
K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc.
K160498Dentivera Milling DiscDental Solutions, LLC
K153590AvaDent Denture Base MaterialGlobal Dental Science
K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries
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.