← Back to catalogue

Straumann MembraGel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082111

by Institut Straumann AG

Identifiers

510(k) Number
K082111 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)

Straumann MembraGel is a validated resorbable membrane system designed for intraoral use. It is a synthetic barrier membrane that biodegrades over time to support undisturbed bone regeneration.

The device is supplied as a liquid membrane and is intended for dental applications. It has been cleared by the FDA as substantially equivalent to predicate devices under product code NPK. The device is available in various sizes as indicated by the multiple registration numbers provided.

Frequently asked questions

What is Straumann MembraGel used for?

Straumann MembraGel is a validated resorbable membrane system designed for intraoral use. It serves as a synthetic barrier membrane that biodegrades over time to support undisturbed bone regeneration in dental applications.

How is Straumann MembraGel supplied?

The device is supplied as a liquid membrane and is available in various sizes as indicated by the multiple registration numbers provided. This allows clinicians to select the appropriate size for their specific dental procedures.

Is Straumann MembraGel a single-use or reusable device?

The device information does not specify whether Straumann MembraGel is single-use or reusable. Clinicians should refer to the product instructions for use to determine the appropriate handling and disposal procedures for this membrane system.

What is the regulatory status of Straumann MembraGel?

Straumann MembraGel has been cleared by the FDA as substantially equivalent to predicate devices under product code NPK. This clearance was granted through the traditional 510(k) process with decision code SESE on May 22, 2009.

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. Sources consulted: STRAUMANN MEMBRAGEL (K101956) — FDA 510 (k) | Innolitics, PDF # shuumann - accessdata.fda.gov, Straumann launches Straumann® MembraGel - Today's Medical Developments, The Membragel Straumann liquid membrane - Zerodonto

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Institut Straumann AG

Sources (1)

  • FDA 510(k) K082111 24 fields · synced Sep 26, 2026