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FDA 510(k)

ALLROUND-E (CODE NAME RD 1710)

K-Number: K984587 · 1999-03-17

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date1999-03-17
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALLROUND-E (CODE NAME RD 1710) 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 1999-03-17 under 510(k) number K984587. 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 ALLROUND-E (CODE NAME RD 1710)?

ALLROUND-E (CODE NAME RD 1710) is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K984587.

When did ALLROUND-E (CODE NAME RD 1710) receive FDA 510(k) clearance?

ALLROUND-E (CODE NAME RD 1710) received FDA 510(k) clearance on 1999-03-17, under 510(k) number K984587.

Who is the listed applicant for ALLROUND-E (CODE NAME RD 1710)?

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 ALLROUND-E (CODE NAME RD 1710)?

The FDA product code for ALLROUND-E (CODE NAME RD 1710) is EJS.

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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.

K012303JEL-20K002993HERACERAMK002645JEL BIOS PUREK002222RD-2104K001360SIGNUMK001260ALLROUND 55 LF

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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.

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