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FDA 510(k)

NANOCOMPOSITE RESTORATIVE KIT

K-Number: K080480 · 2008-05-30

ApplicantDmg USA, Inc.
Decision Date2008-05-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NANOCOMPOSITE RESTORATIVE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080480. 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 NANOCOMPOSITE RESTORATIVE KIT?

NANOCOMPOSITE RESTORATIVE KIT is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Dmg USA, Inc.. The 510(k) number is K080480.

When did NANOCOMPOSITE RESTORATIVE KIT receive FDA 510(k) clearance?

NANOCOMPOSITE RESTORATIVE KIT received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080480.

Who is the listed applicant for NANOCOMPOSITE RESTORATIVE KIT?

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

What is the FDA product code for NANOCOMPOSITE RESTORATIVE KIT?

The FDA product code for NANOCOMPOSITE RESTORATIVE KIT is EBF.

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Other records listing Dmg USA, 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.

K171772Ecosite Bulk FillK160443TempoCem ClearK110759TEMPOCEMK102603SA FLOWABLE ADHESIVEK101710LUXATEMP ULTRA /STARK100062INFILTRATION KIT

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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

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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