Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KB58-KF

K-Number: K922958 · 1993-02-26

ApplicantJeneric/Pentron, Inc.
Decision Date1993-02-26
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KB58-KF 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 1993-02-26 under 510(k) number K922958. 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 KB58-KF?

KB58-KF is a medical device that received FDA 510(k) clearance on 1993-02-26. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K922958.

When did KB58-KF receive FDA 510(k) clearance?

KB58-KF received FDA 510(k) clearance on 1993-02-26, under 510(k) number K922958.

Who is the listed applicant for KB58-KF?

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 KB58-KF?

The FDA product code for KB58-KF is EJS.

Other records listing Jeneric/Pentron, Inc. 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.

K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

View all 78 devices →

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. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland 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.

↑