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FDA 510(k)

GALLOY

K-Number: K955285 · 1996-01-24

ApplicantSouthern Dental Industries, Inc.
Decision Date1996-01-24
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955285. 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 GALLOY?

GALLOY is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K955285.

When did GALLOY receive FDA 510(k) clearance?

GALLOY received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955285.

Who is the listed applicant for GALLOY?

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

What is the FDA product code for GALLOY?

The FDA product code for GALLOY is EJJ.

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Other records listing Southern Dental Industries, 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.

K062065RIVA LUTING PLUSK062064RIVA BOND LCK050871RIVA PROTECTK050870RIVA LIGHT CUREK050331ADHESIVE 1K042452RIVA SILVER

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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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