FDA 510(k)

TERA HARZ 牙托

K号: K222414 · 2022-08-11

决定日期2022-08-11

产品代码EBI

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决定实质等同

器械摘要

TERA HARZ DENTURE is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K222414. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TERA HARZ DENTURE?

TERA HARZ DENTURE is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Graphy, Inc.. The 510(k) number is K222414.

When did TERA HARZ DENTURE receive FDA 510(k) clearance?

TERA HARZ DENTURE received FDA 510(k) clearance on 2022-08-11, under 510(k) number K222414.

Who is the listed applicant for TERA HARZ DENTURE?

The FDA 510(k) record lists Graphy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERA HARZ DENTURE?

The FDA product code for TERA HARZ DENTURE is EBI.

列明Graphy, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253681TERA HARZ 硬牙托 (THD-C-500); TERA HARZ 硬牙托 (THD-C-1000); TERA HARZ 硬牙托 (THD-LP-500); TERA HARZ 硬牙托 (THD-LP-1000); TERA HARZ 硬牙托 (THD-P-500); TERA HARZ 硬牙托 (THD-P-1000); TERA HARZ 硬牙托 (THD-CP-500); TERA HARZ 硬牙托 (THD-CP-1000)K240597TERA HARZ CLEAR K233502TERA HARZ II K223355Tera Harz Clear K202846TERA HARZ

官方来源

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