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FDA 510(k)

RIVA-SELF CURE

K-Number: K030516 · 2003-04-17

ApplicantSouthern Dental Industries, Inc.
Decision Date2003-04-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RIVA-SELF CURE 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 2003-04-17 under 510(k) number K030516. 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-SELF CURE?

RIVA-SELF CURE is a medical device that received FDA 510(k) clearance on 2003-04-17. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K030516.

When did RIVA-SELF CURE receive FDA 510(k) clearance?

RIVA-SELF CURE received FDA 510(k) clearance on 2003-04-17, under 510(k) number K030516.

Who is the listed applicant for RIVA-SELF CURE?

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-SELF CURE?

The FDA product code for RIVA-SELF CURE is EMA.

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.

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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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