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FDA 510(k)

MONDIAL

K-Number: K060994 · 2006-05-22

ApplicantHeraeus Kulzer, Inc.
Decision Date2006-05-22
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MONDIAL 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 2006-05-22 under 510(k) number K060994. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONDIAL?

MONDIAL is a medical device that received FDA 510(k) clearance on 2006-05-22. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K060994.

When did MONDIAL receive FDA 510(k) clearance?

MONDIAL received FDA 510(k) clearance on 2006-05-22, under 510(k) number K060994.

Who is the listed applicant for MONDIAL?

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 MONDIAL?

The FDA product code for MONDIAL is ELM.

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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 2006K052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECTK042878FLEXITIME XTREME

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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