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FDA 510(k)

BIOROOT RCS

K-Number: K130601 · 2013-10-17

ApplicantNovocol, Inc.
Decision Date2013-10-17
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOROOT RCS is the device name listed in this FDA 510(k) record. The listed applicant is Novocol, Inc.. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K130601. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOROOT RCS?

BIOROOT RCS is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Novocol, Inc.. The 510(k) number is K130601.

When did BIOROOT RCS receive FDA 510(k) clearance?

BIOROOT RCS received FDA 510(k) clearance on 2013-10-17, under 510(k) number K130601.

Who is the listed applicant for BIOROOT RCS?

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

What is the FDA product code for BIOROOT RCS?

The FDA product code for BIOROOT RCS is KIF.

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Other records listing Novocol, Inc. 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.

K120237BPA-FREE MICROHYBID COMPOSITEK120283DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTK120619ORTHODONTIC FLOWABLE BRACKET ADHESIVEK110484SELF CURE TEMPORARY CROWN AND BRIDGE MATERIALK092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIALK072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

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Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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