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FDA 510(k)

RX G-UNIVERSAL

K-Number: K000360 · 2000-02-18

ApplicantJeneric/Pentron, Inc.
Decision Date2000-02-18
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX G-UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K000360. 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 RX G-UNIVERSAL?

RX G-UNIVERSAL is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K000360.

When did RX G-UNIVERSAL receive FDA 510(k) clearance?

RX G-UNIVERSAL received FDA 510(k) clearance on 2000-02-18, under 510(k) number K000360.

Who is the listed applicant for RX G-UNIVERSAL?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RX G-UNIVERSAL?

The FDA product code for RX G-UNIVERSAL is EJT.

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Other records listing Jeneric/Pentron, Inc. as applicant

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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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