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FDA 510(k)

JELBOND NP

K-Number: K984164 · 1998-12-29

ApplicantJelenko Co.
Decision Date1998-12-29
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JELBOND NP is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1998-12-29 under 510(k) number K984164. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JELBOND NP?

JELBOND NP is a medical device that received FDA 510(k) clearance on 1998-12-29. The listed applicant is Jelenko Co.. The 510(k) number is K984164.

When did JELBOND NP receive FDA 510(k) clearance?

JELBOND NP received FDA 510(k) clearance on 1998-12-29, under 510(k) number K984164.

Who is the listed applicant for JELBOND NP?

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

What is the FDA product code for JELBOND NP?

The FDA product code for JELBOND NP is EJH.

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Other records listing Jelenko Co. 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.

K010416HERACERAM 75K003603BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HEK964158JEL-40 (CODE NAME RD-0430)K930762SUPERSTARK912194PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEK912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

View all 12 devices →

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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