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FDA 510(k)

IROOT BP, MODEL IRBP 4609

K-Number: K082943 · 2009-01-06

ApplicantInnovative Bioceramix, Inc.
Decision Date2009-01-06
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IROOT BP, MODEL IRBP 4609 is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2009-01-06 under 510(k) number K082943. 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 IROOT BP, MODEL IRBP 4609?

IROOT BP, MODEL IRBP 4609 is a medical device that received FDA 510(k) clearance on 2009-01-06. The listed applicant is Innovative Bioceramix, Inc.. The 510(k) number is K082943.

When did IROOT BP, MODEL IRBP 4609 receive FDA 510(k) clearance?

IROOT BP, MODEL IRBP 4609 received FDA 510(k) clearance on 2009-01-06, under 510(k) number K082943.

Who is the listed applicant for IROOT BP, MODEL IRBP 4609?

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

What is the FDA product code for IROOT BP, MODEL IRBP 4609?

The FDA product code for IROOT BP, MODEL IRBP 4609 is KIF.

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Other records listing Innovative Bioceramix, Inc. as applicant

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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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