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FDA 510(k)

PALADISC LC

K-Number: K923549 · 1992-09-29

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-09-29
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALADISC LC 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 1992-09-29 under 510(k) number K923549. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALADISC LC?

PALADISC LC is a medical device that received FDA 510(k) clearance on 1992-09-29. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K923549.

When did PALADISC LC receive FDA 510(k) clearance?

PALADISC LC received FDA 510(k) clearance on 1992-09-29, under 510(k) number K923549.

Who is the listed applicant for PALADISC LC?

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 PALADISC LC?

The FDA product code for PALADISC LC is EBH.

Related Clinical Trials

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.

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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: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, Inc.K902350PALATRAY LC RESIN IMPRESSION TRAY MATERIALKulzer, 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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