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Graft Bone Substitute

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191737

by PURGO BIOLOGICS Inc.

Identifiers

510(k) Number
K191737 FDA 510(k)
FDA Product Code
NPM 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 Graft Bone Substitute is a Bone Grafting Material, Animal Source, designed to promote bone regeneration and repair in dental procedures. It serves as an alternative to autogenous bone grafts by providing a scaffold and growth factors to support new bone formation in defects or extraction sites.

This material is supplied as a sterile, single-use product and is intended for use in dental settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDD compliance. Multiple lot numbers and registration identifiers confirm its regulatory authorisation for dental bone grafting applications, with no MRI safety restrictions specified.

Frequently asked questions

What types of dental procedures is The Graft Bone Substitute intended to support, and how does it differ from traditional autogenous bone grafts?

The Graft Bone Substitute is designed to promote bone regeneration and repair in dental procedures, specifically in defects or extraction sites where bone volume needs augmentation. Unlike autogenous bone grafts—where bone is harvested from the patient’s own body—this product provides a scaffold and growth factors derived from animal sources to support new bone formation. It serves as a biocompatible alternative that eliminates the need for donor site harvesting while still facilitating effective bone integration.

Is The Graft Bone Substitute reusable, or is it meant for single-use only? How should it be stored?

The Graft Bone Substitute is explicitly supplied as a sterile, single-use product, meaning it should not be reused after opening. To maintain sterility and efficacy, it should be stored according to the manufacturer’s instructions (not provided here, but typically in a dry, sealed environment away from extreme temperatures) until ready for use in dental procedures.

What regulatory pathways has The Graft Bone Substitute undergone, and how does this affect its use in clinical settings?

The Graft Bone Substitute has received FDA 510(k) clearance and complies with the MDD (Medical Device Directive). This means it has been evaluated for safety and effectiveness as a Class II medical device under FDA regulations and is authorized for dental bone grafting applications. Clinicians can rely on its regulatory approval for use in procedures where bone regeneration is required, though adherence to manufacturer guidelines remains critical.

Are there any size variations or models available for The Graft Bone Substitute, and how might this affect its application?

The provided data does not specify distinct size variations or model numbers for The Graft Bone Substitute. However, as a bone grafting material for dental use, it is likely formulated to be adaptable to common defect sizes in extraction sites or bone augmentation procedures. Clinicians should confirm compatibility with their specific case requirements by consulting the manufacturer’s technical documentation or support.

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
PURGO BIOLOGICS Inc.
FDA Applicant
Purgo Biologics, Inc.

Sources (2)

  • FDA 510(k) K191737 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026