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FDA 510(k)

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

K-Number: K002808 · 2000-10-31

ApplicantNordiska Dental AB
Decision Date2000-10-31
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Nordiska Dental AB. It received FDA 510(k) clearance on 2000-10-31 under 510(k) number K002808. 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 ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY?

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 2000-10-31. The listed applicant is Nordiska Dental AB. The 510(k) number is K002808.

When did ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY receive FDA 510(k) clearance?

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY received FDA 510(k) clearance on 2000-10-31, under 510(k) number K002808.

Who is the listed applicant for ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY?

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

What is the FDA product code for ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY?

The FDA product code for ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY is EJJ.

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Other records listing Nordiska Dental AB 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.

K002811ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOYK002810ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOYK992161CERANA

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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