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FDA 510(k)

SIMPLISEAL

K-Number: K093208 · 2010-02-12

ApplicantDiscus Dental, LLC
Decision Date2010-02-12
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLISEAL is the device name listed in this FDA 510(k) record. The listed applicant is Discus Dental, LLC. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K093208. 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 SIMPLISEAL?

SIMPLISEAL is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Discus Dental, LLC. The 510(k) number is K093208.

When did SIMPLISEAL receive FDA 510(k) clearance?

SIMPLISEAL received FDA 510(k) clearance on 2010-02-12, under 510(k) number K093208.

Who is the listed applicant for SIMPLISEAL?

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

What is the FDA product code for SIMPLISEAL?

The FDA product code for SIMPLISEAL is KIF.

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Other records listing Discus Dental, LLC 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.

K102639SL3K101612ZEN CORDLESS PROPHY SYSTEMK101215NUANCEK092417INSIGHT ULTRASONIC INSERTS

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

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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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