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FDA 510(k)

MELIODENT, DENTURE RESIN

K-Number: K910465 · 1991-06-06

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-06-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MELIODENT, DENTURE RESIN 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 1991-06-06 under 510(k) number K910465. 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 MELIODENT, DENTURE RESIN?

MELIODENT, DENTURE RESIN is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K910465.

When did MELIODENT, DENTURE RESIN receive FDA 510(k) clearance?

MELIODENT, DENTURE RESIN received FDA 510(k) clearance on 1991-06-06, under 510(k) number K910465.

Who is the listed applicant for MELIODENT, DENTURE RESIN?

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 MELIODENT, DENTURE RESIN?

The FDA product code for MELIODENT, DENTURE RESIN is EBI.

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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: 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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