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FDA 510(k)

NUANCE

K-Number: K101215 · 2010-05-12

ApplicantDiscus Dental, LLC
Decision Date2010-05-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUANCE 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 2010-05-12 under 510(k) number K101215. 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 NUANCE?

NUANCE is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Discus Dental, LLC. The 510(k) number is K101215.

When did NUANCE receive FDA 510(k) clearance?

NUANCE received FDA 510(k) clearance on 2010-05-12, under 510(k) number K101215.

Who is the listed applicant for NUANCE?

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 NUANCE?

The FDA product code for NUANCE is EBF.

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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 SYSTEMK093208SIMPLISEALK092417INSIGHT ULTRASONIC INSERTS

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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