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FDA 510(k)

STERNGOLD 1, MODEL 1127781

K-Number: K022252 · 2002-09-19

ApplicantSterngold
Decision Date2002-09-19
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNGOLD 1, MODEL 1127781 is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold. It received FDA 510(k) clearance on 2002-09-19 under 510(k) number K022252. 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 1, MODEL 1127781?

STERNGOLD 1, MODEL 1127781 is a medical device that received FDA 510(k) clearance on 2002-09-19. The listed applicant is Sterngold. The 510(k) number is K022252.

When did STERNGOLD 1, MODEL 1127781 receive FDA 510(k) clearance?

STERNGOLD 1, MODEL 1127781 received FDA 510(k) clearance on 2002-09-19, under 510(k) number K022252.

Who is the listed applicant for STERNGOLD 1, MODEL 1127781?

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 1, MODEL 1127781?

The FDA product code for STERNGOLD 1, MODEL 1127781 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 SYSTEMK021741CRITERTION, MODEL #1067511K021045ERA IMPLANTK021367STERNGOLD 66, MODEL #1180230

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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. KGK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020192SIMIDUR 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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