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)

FLOW LINE

K-Number: K990756 · 1999-05-07

ApplicantHeraeus Kulzer, Inc.
Decision Date1999-05-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOW LINE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1999-05-07 under 510(k) number K990756. 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 FLOW LINE?

FLOW LINE is a medical device that received FDA 510(k) clearance on 1999-05-07. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K990756.

When did FLOW LINE receive FDA 510(k) clearance?

FLOW LINE received FDA 510(k) clearance on 1999-05-07, under 510(k) number K990756.

Who is the listed applicant for FLOW LINE?

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

What is the FDA product code for FLOW LINE?

The FDA product code for FLOW LINE is EBF.

Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

View all 145 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.

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.

↑