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FDA 510(k)

RIVA PROTECT

K-Number: K050871 · 2005-06-10

ApplicantSouthern Dental Industries, Inc.
Decision Date2005-06-10
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RIVA PROTECT 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 2005-06-10 under 510(k) number K050871. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIVA PROTECT?

RIVA PROTECT is a medical device that received FDA 510(k) clearance on 2005-06-10. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K050871.

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

RIVA PROTECT received FDA 510(k) clearance on 2005-06-10, under 510(k) number K050871.

Who is the listed applicant for RIVA PROTECT?

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 PROTECT?

The FDA product code for RIVA PROTECT is EBC.

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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 LCK050870RIVA LIGHT CUREK050331ADHESIVE 1K042452RIVA SILVERK040393RIVA LUTING

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar 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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