Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

K-Number: K063549 · 2007-02-12

ApplicantNovabone Products, LLC
Decision Date2007-02-12
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2007-02-12 under 510(k) number K063549. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT?

NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT is a medical device that received FDA 510(k) clearance on 2007-02-12. The listed applicant is Novabone Products, LLC. The 510(k) number is K063549.

When did NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT receive FDA 510(k) clearance?

NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT received FDA 510(k) clearance on 2007-02-12, under 510(k) number K063549.

Who is the listed applicant for NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT?

The FDA 510(k) record lists Novabone Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT?

The FDA product code for NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT is LYC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Novabone Products, LLC 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.

K242299NovaBone Putty - Synthetic Bioactive Bone GraftK240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)K220498NovoGen Wound MatrixK163310NovaBone IRMK112428NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFTK112773NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT

View all 26 devices →

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑