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FDA 510(k)

DEFINITE

K-Number: K993514 · 2000-02-24

ApplicantDegussa - Ney Dental, Inc.
Decision Date2000-02-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEFINITE is the device name listed in this FDA 510(k) record. The listed applicant is Degussa - Ney Dental, Inc.. It received FDA 510(k) clearance on 2000-02-24 under 510(k) number K993514. 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 DEFINITE?

DEFINITE is a medical device that received FDA 510(k) clearance on 2000-02-24. The listed applicant is Degussa - Ney Dental, Inc.. The 510(k) number is K993514.

When did DEFINITE receive FDA 510(k) clearance?

DEFINITE received FDA 510(k) clearance on 2000-02-24, under 510(k) number K993514.

Who is the listed applicant for DEFINITE?

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

What is the FDA product code for DEFINITE?

The FDA product code for DEFINITE is EBF.

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Other records listing Degussa - Ney Dental, 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.

K013230CERCON BASEK011333CERCON CERAMK993897CERGOGOLD

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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