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FDA 510(k)

GALAXY

K-Number: K003007 · 2000-11-17

ApplicantSterngold
Decision Date2000-11-17
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GALAXY is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold. It received FDA 510(k) clearance on 2000-11-17 under 510(k) number K003007. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY?

GALAXY is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is Sterngold. The 510(k) number is K003007.

When did GALAXY receive FDA 510(k) clearance?

GALAXY received FDA 510(k) clearance on 2000-11-17, under 510(k) number K003007.

Who is the listed applicant for GALAXY?

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 GALAXY?

The FDA product code for GALAXY is EJT.

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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 1127781K021741CRITERTION, MODEL #1067511K021045ERA IMPLANT

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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