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FDA 510(k)

OSTEOGRAF/N-300

K-Number: K981182 · 1998-07-02

ApplicantCeramed Dental, LLC
Decision Date1998-07-02
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/N-300 is the device name listed in this FDA 510(k) record. The listed applicant is Ceramed Dental, LLC. It received FDA 510(k) clearance on 1998-07-02 under 510(k) number K981182. 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 OSTEOGRAF/N-300?

OSTEOGRAF/N-300 is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Ceramed Dental, LLC. The 510(k) number is K981182.

When did OSTEOGRAF/N-300 receive FDA 510(k) clearance?

OSTEOGRAF/N-300 received FDA 510(k) clearance on 1998-07-02, under 510(k) number K981182.

Who is the listed applicant for OSTEOGRAF/N-300?

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

What is the FDA product code for OSTEOGRAF/N-300?

The FDA product code for OSTEOGRAF/N-300 is LYC.

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Other records listing Ceramed Dental, 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.

K981214OSTEOGRAF/N-700

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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