FDA 510(k)

STERNGOLD G-HARD METAL ALLOY

K-Number: K962301 · 1996-07-18

Decision Date1996-07-18

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

STERNGOLD G-HARD METAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is The Stern Metals Co., Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K962301. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNGOLD G-HARD METAL ALLOY?

STERNGOLD G-HARD METAL ALLOY is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is The Stern Metals Co., Inc.. The 510(k) number is K962301.

When did STERNGOLD G-HARD METAL ALLOY receive FDA 510(k) clearance?

STERNGOLD G-HARD METAL ALLOY received FDA 510(k) clearance on 1996-07-18, under 510(k) number K962301.

Who is the listed applicant for STERNGOLD G-HARD METAL ALLOY?

The FDA 510(k) record lists The Stern Metals Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERNGOLD G-HARD METAL ALLOY?

The FDA product code for STERNGOLD G-HARD METAL ALLOY is EJS.

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Other records listing The Stern Metals Co., Inc. as applicant

K933193IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L K926305IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER K924219ENDOSSEOUS IMPLANTS

Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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.