FDA 510(k)

JEL-20

K-Number: K012303 · 2001-08-22

Decision Date2001-08-22

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

JEL-20 is the device name listed in this FDA 510(k) record. The listed applicant is J.F. Jelenko & Co., Inc.. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K012303. 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 JEL-20?

JEL-20 is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K012303.

When did JEL-20 receive FDA 510(k) clearance?

JEL-20 received FDA 510(k) clearance on 2001-08-22, under 510(k) number K012303.

Who is the listed applicant for JEL-20?

The FDA 510(k) record lists J.F. Jelenko & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JEL-20?

The FDA product code for JEL-20 is EJS.

Other records listing J.F. Jelenko & Co., 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.

K002993HERACERAM K002645JEL BIOS PURE K002222RD-2104 K001360SIGNUM K001260ALLROUND 55 LF K001196JEL BIOS 90 (CODE NAME RD-2401)

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR 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.