Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NMF004A

K-Number: K173500 · 2018-03-08

ApplicantGC America, Inc.
Decision Date2018-03-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NMF004A is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K173500. 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 NMF004A?

NMF004A is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is GC America, Inc.. The 510(k) number is K173500.

When did NMF004A receive FDA 510(k) clearance?

NMF004A received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173500.

Who is the listed applicant for NMF004A?

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

What is the FDA product code for NMF004A?

The FDA product code for NMF004A is EBF.

Other records listing GC America, 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.

K253317Cytrans™ ElashieldK261246SRGC-06K254109G-CEM UNIVERSALK251124G-Bond UniversalK250953EQUIA LC ONEK251946G aenial Universal Injectable II

View all 24 devices →

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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.

↑