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FDA 510(k)

ORTHO WAX

K-Number: K924024 · 1992-11-17

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-11-17
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO WAX 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 1992-11-17 under 510(k) number K924024. 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 ORTHO WAX?

ORTHO WAX is a medical device that received FDA 510(k) clearance on 1992-11-17. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K924024.

When did ORTHO WAX receive FDA 510(k) clearance?

ORTHO WAX received FDA 510(k) clearance on 1992-11-17, under 510(k) number K924024.

Who is the listed applicant for ORTHO WAX?

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 ORTHO WAX?

The FDA product code for ORTHO WAX is EGD.

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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

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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 TechnologiesK923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.K914513PALAVIT GHeraeus Kulzer, 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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