FDA 510(k)

TEA HA ZI CHING CHUAN

K 號：K240597 · 2024-03-05

決定日期2024-03-05

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

TERA HARZ CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K240597. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TERA HARZ CLEAR?

TERA HARZ CLEAR is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Graphy, Inc.. The 510(k) number is K240597.

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

TERA HARZ CLEAR received FDA 510(k) clearance on 2024-03-05, under 510(k) number K240597.

Who is the listed applicant for TERA HARZ CLEAR?

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 CLEAR?

The FDA product code for TERA HARZ CLEAR is NXC.

其他以 Graphy, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253681TEERA HARZ 硬質假牙 (THD-C-500)；TEERA HARZ 硬質假牙 (THD-C-1000)；TEERA HARZ 硬質假牙 (THD-LP-500)；TEERA HARZ 硬質假牙 (THD-LP-1000)；TEERA HARZ 硬質假牙 (THD-P-500)；TEERA HARZ 硬質假牙 (THD-P-1000)；TEERA HARZ 硬質假牙 (THD-CP-500)；TEERA HARZ 硬質假牙 (THD-CP-1000)K233502TEA HARZ II K223355Tera Harz Clear K222414特瑞哈茲假牙 K202846TEA HA ZI

相關器械（代碼：NXC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260527臉部4D調整器Avinent Implant System S.L.U.K260788斯麥麗歐正畸器Smylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile系統Dror Orthodesign , Ltd.K251454清齊正齊器（SCF-3348）Beame Medical Technology (Shenzhen) Limited K250739Primeprint直接對齊器Dreve Dentamid GmbH

官方來源

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