FDA 510(k)

Silent Nite® 睡眠呼吸器配Glidewell Hinge™ (SNGLHG)

K 號：K233434 · 2023-11-14

決定日期2023-11-14

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K233434. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K233434.

When did Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) receive FDA 510(k) clearance?

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) received FDA 510(k) clearance on 2023-11-14, under 510(k) number K233434.

Who is the listed applicant for Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

FDA 510(k) 記錄將 Prismatik Dentalcraft, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

The FDA product code for Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is LRK.

其他以 Prismatik Dentalcraft, 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。

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相關器械（代碼：LRK）

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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