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FDA 510(k)

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE

K-Number: K000149 · 2000-02-07

ApplicantUsbiomaterials Corp.
Decision Date2000-02-07
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE is the device name listed in this FDA 510(k) record. The listed applicant is Usbiomaterials Corp.. It received FDA 510(k) clearance on 2000-02-07 under 510(k) number K000149. 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-BIOGLASS BONE GRAFT PARTICULATE?

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE is a medical device that received FDA 510(k) clearance on 2000-02-07. The listed applicant is Usbiomaterials Corp.. The 510(k) number is K000149.

When did NOVABONE-BIOGLASS BONE GRAFT PARTICULATE receive FDA 510(k) clearance?

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE received FDA 510(k) clearance on 2000-02-07, under 510(k) number K000149.

Who is the listed applicant for NOVABONE-BIOGLASS BONE GRAFT PARTICULATE?

The FDA 510(k) record lists Usbiomaterials Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVABONE-BIOGLASS BONE GRAFT PARTICULATE?

The FDA product code for NOVABONE-BIOGLASS BONE GRAFT PARTICULATE is LYC.

Related Clinical Trials

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Other records listing Usbiomaterials Corp. 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.

K024343BUTLER GUM PROPHY PASTE WITH NOVAMINK992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATEK962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATEK930115PERIOGLASS

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.

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