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FDA 510(k)

OSTEOGEN (HA RESORB)

K-Number: K923310 · 1995-05-31

ApplicantImpladent
Decision Date1995-05-31
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGEN (HA RESORB) is the device name listed in this FDA 510(k) record. The listed applicant is Impladent. It received FDA 510(k) clearance on 1995-05-31 under 510(k) number K923310. 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 OSTEOGEN (HA RESORB)?

OSTEOGEN (HA RESORB) is a medical device that received FDA 510(k) clearance on 1995-05-31. The listed applicant is Impladent. The 510(k) number is K923310.

When did OSTEOGEN (HA RESORB) receive FDA 510(k) clearance?

OSTEOGEN (HA RESORB) received FDA 510(k) clearance on 1995-05-31, under 510(k) number K923310.

Who is the listed applicant for OSTEOGEN (HA RESORB)?

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

What is the FDA product code for OSTEOGEN (HA RESORB)?

The FDA product code for OSTEOGEN (HA RESORB) 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.

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Other records listing Impladent 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.

K881662EXPANDED CLAIMES TO OSTEOGEN(R)K843398OSTEOGENK812321HYDROXI-FLEX IMPLANTK792663FLEXI-CUP IMPLANT

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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