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FDA 510(k)

STERNGOLD 66, MODEL #1180230

K-Number: K021367 · 2002-05-16

ApplicantSterngold
Decision Date2002-05-16
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNGOLD 66, MODEL #1180230 is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K021367. 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 66, MODEL #1180230?

STERNGOLD 66, MODEL #1180230 is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Sterngold. The 510(k) number is K021367.

When did STERNGOLD 66, MODEL #1180230 receive FDA 510(k) clearance?

STERNGOLD 66, MODEL #1180230 received FDA 510(k) clearance on 2002-05-16, under 510(k) number K021367.

Who is the listed applicant for STERNGOLD 66, MODEL #1180230?

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

What is the FDA product code for STERNGOLD 66, MODEL #1180230?

The FDA product code for STERNGOLD 66, MODEL #1180230 is EJS.

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Other records listing Sterngold 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.

K092434STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEMK041271STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEMK023580STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEMK022252STERNGOLD 1, MODEL 1127781K021045ERA IMPLANTK021741CRITERTION, MODEL #1067511

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK020192SIMIDUR S2Wieland Dental + Technik GmbH & Co. KGK020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KG

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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