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FDA 510(k)

MAXCEM

K-Number: K041474 · 2004-07-21

ApplicantSybron Dental Specialties, Inc.
Decision Date2004-07-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXCEM is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 2004-07-21 under 510(k) number K041474. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXCEM?

MAXCEM is a medical device that received FDA 510(k) clearance on 2004-07-21. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K041474.

When did MAXCEM receive FDA 510(k) clearance?

MAXCEM received FDA 510(k) clearance on 2004-07-21, under 510(k) number K041474.

Who is the listed applicant for MAXCEM?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXCEM?

The FDA product code for MAXCEM is EMA.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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