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FDA 510(k)

ARDENT FUTURA NON GAMMA-2

K-Number: K964775 · 1996-12-10

ApplicantArdent Production Development
Decision Date1996-12-10
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARDENT FUTURA NON GAMMA-2 is the device name listed in this FDA 510(k) record. The listed applicant is Ardent Production Development. It received FDA 510(k) clearance on 1996-12-10 under 510(k) number K964775. 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 ARDENT FUTURA NON GAMMA-2?

ARDENT FUTURA NON GAMMA-2 is a medical device that received FDA 510(k) clearance on 1996-12-10. The listed applicant is Ardent Production Development. The 510(k) number is K964775.

When did ARDENT FUTURA NON GAMMA-2 receive FDA 510(k) clearance?

ARDENT FUTURA NON GAMMA-2 received FDA 510(k) clearance on 1996-12-10, under 510(k) number K964775.

Who is the listed applicant for ARDENT FUTURA NON GAMMA-2?

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

What is the FDA product code for ARDENT FUTURA NON GAMMA-2?

The FDA product code for ARDENT FUTURA NON GAMMA-2 is EJJ.

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Other records listing Ardent Production Development 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.

K964192ARDENT NON GAMMA-2 70

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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