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FDA 510(k)

REGEN BIOCEMENT

K-Number: K063010 · 2006-11-28

ApplicantSteiner Laboratories
Decision Date2006-11-28
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REGEN BIOCEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Steiner Laboratories. It received FDA 510(k) clearance on 2006-11-28 under 510(k) number K063010. 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 REGEN BIOCEMENT?

REGEN BIOCEMENT is a medical device that received FDA 510(k) clearance on 2006-11-28. The listed applicant is Steiner Laboratories. The 510(k) number is K063010.

When did REGEN BIOCEMENT receive FDA 510(k) clearance?

REGEN BIOCEMENT received FDA 510(k) clearance on 2006-11-28, under 510(k) number K063010.

Who is the listed applicant for REGEN BIOCEMENT?

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

What is the FDA product code for REGEN BIOCEMENT?

The FDA product code for REGEN BIOCEMENT is LYC.

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Other records listing Steiner Laboratories 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.

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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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