FDA 510(k)

Ormco Spark 調整器系統

K 號：K182826 · 2018-10-11

決定日期2018-10-11

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Ormco Spark Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K182826. 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 Ormco Spark Aligner System?

Ormco Spark Aligner System is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Sybron Dental Specialties. The 510(k) number is K182826.

When did Ormco Spark Aligner System receive FDA 510(k) clearance?

Ormco Spark Aligner System received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182826.

Who is the listed applicant for Ormco Spark Aligner System?

The FDA 510(k) record lists Sybron Dental Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ormco Spark Aligner System?

The FDA product code for Ormco Spark Aligner System is NXC.

其他以 Sybron Dental Specialties 為申請人之記錄

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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。

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