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FDA 510(k)

DENTAL AMALGAM ALLOY

K-Number: K821226 · 1982-06-07

ApplicantDental Alloyers Intl., Inc.
Decision Date1982-06-07
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL AMALGAM ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Dental Alloyers Intl., Inc.. It received FDA 510(k) clearance on 1982-06-07 under 510(k) number K821226. 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 DENTAL AMALGAM ALLOY?

DENTAL AMALGAM ALLOY is a medical device that received FDA 510(k) clearance on 1982-06-07. The listed applicant is Dental Alloyers Intl., Inc.. The 510(k) number is K821226.

When did DENTAL AMALGAM ALLOY receive FDA 510(k) clearance?

DENTAL AMALGAM ALLOY received FDA 510(k) clearance on 1982-06-07, under 510(k) number K821226.

Who is the listed applicant for DENTAL AMALGAM ALLOY?

The FDA 510(k) record lists Dental Alloyers Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL AMALGAM ALLOY?

The FDA product code for DENTAL AMALGAM ALLOY is EJJ.

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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

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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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