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)

REVEAL Bulk

K-Number: K171147 · 2017-08-04

ApplicantBisco, Inc.
Decision Date2017-08-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVEAL Bulk is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K171147. 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 REVEAL Bulk?

REVEAL Bulk is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Bisco, Inc.. The 510(k) number is K171147.

When did REVEAL Bulk receive FDA 510(k) clearance?

REVEAL Bulk received FDA 510(k) clearance on 2017-08-04, under 510(k) number K171147.

Who is the listed applicant for REVEAL Bulk?

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

What is the FDA product code for REVEAL Bulk?

The FDA product code for REVEAL Bulk is EBF.

Other records listing Bisco, 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.

K250156Choice 2 DCK242816QuantiumK192007TheraBase, TheraBase CaK182917FluoroCalK180344TheraCal DCK162598HAPI Seal

View all 10 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.

↑