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FDA 510(k)

NOVUS BONDING AGENT

K-Number: K900301 · 1990-05-15

ApplicantThe Hygenic Corp.
Decision Date1990-05-15
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOVUS BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K900301. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVUS BONDING AGENT?

NOVUS BONDING AGENT is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is The Hygenic Corp.. The 510(k) number is K900301.

When did NOVUS BONDING AGENT receive FDA 510(k) clearance?

NOVUS BONDING AGENT received FDA 510(k) clearance on 1990-05-15, under 510(k) number K900301.

Who is the listed applicant for NOVUS BONDING AGENT?

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

What is the FDA product code for NOVUS BONDING AGENT?

The FDA product code for NOVUS BONDING AGENT is EBI.

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Other records listing The Hygenic Corp. 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.

K954990DENTAL DAMK930764ENDO-ICE-PULP TESTER-THERMALK905418GATES GLIDDEN DRILLSK911225TRAY DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900844WEDJETS

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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