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InnoGenic Non-resorbable Membrane

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211554

by Cowellmedi Co., Ltd

Identifiers

510(k) Number
K211554 FDA 510(k)
FDA Product Code
NPK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The InnoGenic Non-resorbable Membrane is a synthetic barrier device designed for intraoral use. Classified as a Class II medical device under FDA regulations, it functions as a protective membrane to support tissue regeneration and guide bone healing in dental procedures, particularly in guided bone regeneration and periodontal applications.

This membrane is supplied in sterile, single-use packaging and is intended for surgical use in dental settings. Available in various sizes and configurations, it adheres to FDA 510(k) clearance and MDD authorization standards. Storage requires adherence to manufacturer guidelines to maintain sterility, and its use is governed by regulatory compliance with dental barrier device specifications under regulation number 872.3930.

Frequently asked questions

What is the primary purpose of the InnoGenic Non-resorbable Membrane in dental procedures?

The InnoGenic Non-resorbable Membrane acts as a protective barrier to support tissue regeneration and guide bone healing during dental procedures. It is specifically designed for use in guided bone regeneration and periodontal applications, helping to create a favorable environment for healing while preventing unwanted tissue growth.

Is the InnoGenic Non-resorbable Membrane intended for single-use or can it be reused?

The InnoGenic Non-resorbable Membrane is supplied in sterile, single-use packaging, meaning it is intended for one-time use only. Reuse is not recommended or supported by the manufacturer to maintain sterility and ensure patient safety.

What sizes and configurations are available for the InnoGenic Non-resorbable Membrane?

The InnoGenic Non-resorbable Membrane is available in various sizes and configurations, though the exact dimensions are not specified in the provided data. The product is categorized under the FDA’s product code NPK for barrier devices, indicating it is tailored to fit different dental regeneration needs.

How should the InnoGenic Non-resorbable Membrane be stored to maintain its sterility?

The membrane must be stored according to the manufacturer’s guidelines to preserve sterility. Since it is supplied in sterile packaging, it should remain unopened and protected from contamination until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these factors could compromise its integrity.

What regulatory pathways does the InnoGenic Non-resorbable Membrane follow for approval?

The InnoGenic Non-resorbable Membrane follows the FDA’s 510(k) clearance process, classified as a Class II medical device under regulation number 872.3930. It is also authorized under the Medical Device Directive (MDD) and was submitted to the FDA’s Dental (DE) Advisory Committee for review. The device was determined to be substantially equivalent to a predicate, with a clearance date of February 24, 2023.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cowellmedi Co., Ltd
FDA Applicant
Cowellmedi Co., Ltd.

Sources (2)

  • FDA 510(k) K211554 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026