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FDA 510(k)

GOLD CORE PLUS

K-Number: K023499 · 2003-01-13

ApplicantPentron Laboratory Technologies
Decision Date2003-01-13
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD CORE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Laboratory Technologies. It received FDA 510(k) clearance on 2003-01-13 under 510(k) number K023499. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD CORE PLUS?

GOLD CORE PLUS is a medical device that received FDA 510(k) clearance on 2003-01-13. The listed applicant is Pentron Laboratory Technologies. The 510(k) number is K023499.

When did GOLD CORE PLUS receive FDA 510(k) clearance?

GOLD CORE PLUS received FDA 510(k) clearance on 2003-01-13, under 510(k) number K023499.

Who is the listed applicant for GOLD CORE PLUS?

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

What is the FDA product code for GOLD CORE PLUS?

The FDA product code for GOLD CORE PLUS is EJH.

Other records listing Pentron Laboratory Technologies 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.

K023742SCULPTURE PLUS NANO-HYBRID COMPOSITEK023502JEWEL CAST PLUSK023501GOLD CORE 35K020555SONATA MICRO HYBRID COMPOSITE

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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