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FDA PMA

骨移植材質,牙科,含生物成分

PMA 核准號:P040013 · 2026-08-03

決定日期2026-08-03
PMA 編號P040013
產品代碼NPZ
器械分類3 類
醫療專科D
法規編號21 CFR 8
諮詢委員會DE

器材摘要

Bone grafting material, dental, with biologic component is the device name listed in this FDA 510(k) record. The listed applicant is Lynch Biologics, LLC. It received FDA 510(k) clearance on 2026-08-03. The device is classified under product code NPZ. It was reviewed by the DE advisory panel.

常見問題

What is the Bone grafting material, dental, with biologic component?

Bone grafting material, dental, with biologic component is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is Lynch Biologics, LLC.

When did Bone grafting material, dental, with biologic component receive FDA 510(k) clearance?

The clearance date for Bone grafting material, dental, with biologic component can be found in the official FDA records.

誰是骨移植材料,牙科,含生物成分的列名申請人?

The FDA 510(k) record lists Lynch Biologics, LLC as the applicant. This does not by itself establish the device manufacturer.

何為骨移植材料(牙科,含生物成分)的FDA產品代碼?

FDA對骨移植材質、牙科用、含生物成分的產品編碼為NPZ。

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官方來源

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