NovaBone Dental Morsels – Bioactive Synthetic Bone Graft

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K112428

Identifiers

510(k) Number: K112428 FDA 510(k)
FDA Product Code: LYC 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 NovaBone Dental Morsels are a synthetic bone grafting material designed to promote bone regeneration. Classified as a synthetic bone graft substitute, this bioactive material is engineered to support osseous healing in dental procedures, providing a scaffold for new bone formation while integrating with surrounding tissue.

Supplied as a sterile, single-use product, the NovaBone Dental Morsels are intended for use in dental surgeries, including bone augmentation and ridge preservation. The material is regulated under FDA 510K clearance and MDD compliance, with a device classification of Class II. Packaging and storage must adhere to manufacturer guidelines to maintain sterility and efficacy, ensuring compatibility with standard dental operating environments.

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: Reforming Patients Futures - NovaBone, Aktion NovaBone – Die nächste Generation synthetischer Kn, Our Products for 2026 - NovaBone, NovaBone Putty™ | bei Kröner Medizintechnik - kroener-medical.de, Novabone® - Via 4 Spine Wirbelsäulenchirurgie

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K112428	Class II	Active

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Manufacturer

Manufacturer: NovaBone Products, LLC

Sources (2)

FDA 510(k) K112428 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026