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FDA 510(k)

STRAUMANN MEMBRAGEL

K-Number: K101956 · 2010-12-16

ApplicantStraumann USA (On Behalf of Institut Straumann Ag)
Decision Date2010-12-16
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN MEMBRAGEL is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K101956. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN MEMBRAGEL?

STRAUMANN MEMBRAGEL is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Straumann USA (On Behalf of Institut Straumann Ag). The 510(k) number is K101956.

When did STRAUMANN MEMBRAGEL receive FDA 510(k) clearance?

STRAUMANN MEMBRAGEL received FDA 510(k) clearance on 2010-12-16, under 510(k) number K101956.

Who is the listed applicant for STRAUMANN MEMBRAGEL?

The FDA 510(k) record lists Straumann USA (On Behalf of Institut Straumann Ag) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRAUMANN MEMBRAGEL?

The FDA product code for STRAUMANN MEMBRAGEL is NPK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Straumann USA (On Behalf of Institut Straumann Ag) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071919P.004 ABUTMENTS

Related Devices (Code: NPK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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