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FDA 510(k)

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

K-Number: K192042 · 2019-08-29

ApplicantGeistlich Pharma AG
Decision Date2019-08-29
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2019-08-29 under approval number K192042. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal?

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Geistlich Pharma AG. The 510(k) number is K192042.

When was Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal approved by the FDA?

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal received FDA 510(k) clearance on 2019-08-29, under approval number K192042.

What company makes Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal?

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal is manufactured by Geistlich Pharma AG.

What is the FDA product code for Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal?

The FDA product code for Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal is NPL.

Related Clinical Trials

NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT05743673 SHAPE Test for Preoperative Risk Stratification RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07360730 High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry COMPLETED

Other Devices by Geistlich Pharma AG

K171050Geistlich Fibro-Gide K171842Geistlich Wound Matrix K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed K182838Geistlich Derma-Gide K190754Orthoss(R) K203496Nexo-Gide Bilayer Collagen Membrane

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Related Devices (Code: NPL)

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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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