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FDA 510(k)

VIVALLOY HR

K-Number: K982458 · 1998-08-24

ApplicantAb Ardent
Decision Date1998-08-24
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIVALLOY HR is the device name listed in this FDA 510(k) record. The listed applicant is Ab Ardent. It received FDA 510(k) clearance on 1998-08-24 under 510(k) number K982458. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVALLOY HR?

VIVALLOY HR is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Ab Ardent. The 510(k) number is K982458.

When did VIVALLOY HR receive FDA 510(k) clearance?

VIVALLOY HR received FDA 510(k) clearance on 1998-08-24, under 510(k) number K982458.

Who is the listed applicant for VIVALLOY HR?

The FDA 510(k) record lists Ab Ardent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVALLOY HR?

The FDA product code for VIVALLOY HR is EJJ.

Related Clinical Trials

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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Other records listing Ab Ardent 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.

K131753MERIDIANK040465LATIT FLOWK022971MICROHYBRID 11K022972MICROFILL 13K022973ADHESIVE 14K022975ETCHING 15

View all 13 devices →

Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

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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