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FDA 510(k)

FIBER DISK AND BLOCK PERMANENT, TRINIA

K-Number: K121735 · 2013-02-21

ApplicantBioloren S.R.L.
Decision Date2013-02-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBER DISK AND BLOCK PERMANENT, TRINIA 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 2013-02-21 under 510(k) number K121735. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER DISK AND BLOCK PERMANENT, TRINIA?

FIBER DISK AND BLOCK PERMANENT, TRINIA is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Bioloren S.R.L.. The 510(k) number is K121735.

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

FIBER DISK AND BLOCK PERMANENT, TRINIA received FDA 510(k) clearance on 2013-02-21, under 510(k) number K121735.

Who is the listed applicant for FIBER DISK AND BLOCK PERMANENT, TRINIA?

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 PERMANENT, TRINIA?

The FDA product code for FIBER DISK AND BLOCK PERMANENT, TRINIA is EBF.

Related Clinical Trials

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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 ArchesK112186FIBER DISK AND BLOCK

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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