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FDA 510(k)

AMALCAP PLUS

K-Number: K982456 · 1998-08-24

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

Device Summary

AMALCAP PLUS 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 K982456. 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 AMALCAP PLUS?

AMALCAP PLUS 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 K982456.

When did AMALCAP PLUS receive FDA 510(k) clearance?

AMALCAP PLUS received FDA 510(k) clearance on 1998-08-24, under 510(k) number K982456.

Who is the listed applicant for AMALCAP PLUS?

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 AMALCAP PLUS?

The FDA product code for AMALCAP PLUS is EJJ.

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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

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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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