FDA 510(k)

TEA HA ZI

K 號：K202846 · 2021-07-15

決定日期2021-07-15

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

TERA HARZ is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K202846. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TERA HARZ?

TERA HARZ is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Graphy, Inc.. The 510(k) number is K202846.

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

TERA HARZ received FDA 510(k) clearance on 2021-07-15, under 510(k) number K202846.

Who is the listed applicant for TERA HARZ?

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?

The FDA product code for TERA HARZ is EBF.

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)K240597TEA HA ZI CHING CHUAN K233502TEA HARZ II K223355Tera Harz Clear K222414特瑞哈茲假牙

相關器械（代碼：EBF）

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

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