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FDA 510(k)

GOLD CORE 35

K-Number: K023501 · 2002-12-18

ApplicantPentron Laboratory Technologies
Decision Date2002-12-18
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD CORE 35 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 2002-12-18 under 510(k) number K023501. 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 GOLD CORE 35?

GOLD CORE 35 is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Pentron Laboratory Technologies. The 510(k) number is K023501.

When did GOLD CORE 35 receive FDA 510(k) clearance?

GOLD CORE 35 received FDA 510(k) clearance on 2002-12-18, under 510(k) number K023501.

Who is the listed applicant for GOLD CORE 35?

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 35?

The FDA product code for GOLD CORE 35 is EJT.

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 COMPOSITEK023499GOLD CORE PLUSK023502JEWEL CAST PLUSK020555SONATA MICRO HYBRID COMPOSITE

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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