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FDA 510(k)

FIBER DISK AND BLOCK

K-Number: K112186 · 2011-11-08

ApplicantBioloren S.R.L.
Decision Date2011-11-08
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBER DISK AND BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Bioloren S.R.L.. It received FDA 510(k) clearance on 2011-11-08 under 510(k) number K112186. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER DISK AND BLOCK?

FIBER DISK AND BLOCK is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Bioloren S.R.L.. The 510(k) number is K112186.

When did FIBER DISK AND BLOCK receive FDA 510(k) clearance?

FIBER DISK AND BLOCK received FDA 510(k) clearance on 2011-11-08, under 510(k) number K112186.

Who is the listed applicant for FIBER DISK AND BLOCK?

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

What is the FDA product code for FIBER DISK AND BLOCK?

The FDA product code for FIBER DISK AND BLOCK is EBG.

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 Bioloren S.R.L. 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.

K173643Trilor Disks, Blocks and ArchesK121735FIBER DISK AND BLOCK PERMANENT, TRINIA

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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