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FDA 510(k)

RIVA LUTING

K-Number: K040393 · 2004-04-30

ApplicantSouthern Dental Industries, Inc.
Decision Date2004-04-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RIVA LUTING is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Inc.. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040393. 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 RIVA LUTING?

RIVA LUTING is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K040393.

When did RIVA LUTING receive FDA 510(k) clearance?

RIVA LUTING received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040393.

Who is the listed applicant for RIVA LUTING?

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

What is the FDA product code for RIVA LUTING?

The FDA product code for RIVA LUTING is EMA.

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Other records listing Southern Dental Industries, 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.

K062065RIVA LUTING PLUSK062064RIVA BOND LCK050871RIVA PROTECTK050870RIVA LIGHT CUREK050331ADHESIVE 1K042452RIVA SILVER

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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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