FDA 510(k)

特瑞哈茲假牙

K 號：K222414 · 2022-08-11

決定日期2022-08-11

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

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 K202846TEA HA ZI

相關器械（代碼：EBI）

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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

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