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FDA 510(k)

ULTRA SPHERICAL AMALGAM ALLOY

K-Number: K951865 · 1995-05-25

ApplicantGoldsmith & Revere, Inc.
Decision Date1995-05-25
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRA SPHERICAL AMALGAM ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Goldsmith & Revere, Inc.. It received FDA 510(k) clearance on 1995-05-25 under 510(k) number K951865. 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 ULTRA SPHERICAL AMALGAM ALLOY?

ULTRA SPHERICAL AMALGAM ALLOY is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Goldsmith & Revere, Inc.. The 510(k) number is K951865.

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

ULTRA SPHERICAL AMALGAM ALLOY received FDA 510(k) clearance on 1995-05-25, under 510(k) number K951865.

Who is the listed applicant for ULTRA SPHERICAL AMALGAM ALLOY?

The FDA 510(k) record lists Goldsmith & Revere, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA SPHERICAL AMALGAM ALLOY?

The FDA product code for ULTRA SPHERICAL AMALGAM ALLOY 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 Goldsmith & Revere, Inc. 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.

K933309PRINCEK821222GOLDSMITH & REVERE TENARY ALLOYK820617DISPERSED PHASE ALLOY

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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