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FDA 510(k)

PREMIUM FLEXI-TOUGH

K-Number: K854530 · 1986-03-04

ApplicantThe Hygenic Corp.
Decision Date1986-03-04
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM FLEXI-TOUGH 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 1986-03-04 under 510(k) number K854530. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIUM FLEXI-TOUGH?

PREMIUM FLEXI-TOUGH is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is The Hygenic Corp.. The 510(k) number is K854530.

When did PREMIUM FLEXI-TOUGH receive FDA 510(k) clearance?

PREMIUM FLEXI-TOUGH received FDA 510(k) clearance on 1986-03-04, under 510(k) number K854530.

Who is the listed applicant for PREMIUM FLEXI-TOUGH?

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 PREMIUM FLEXI-TOUGH?

The FDA product code for PREMIUM FLEXI-TOUGH is EGD.

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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 CARRIERK900301NOVUS BONDING AGENT

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Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.

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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