FDA 510(k)

VERA PDN

K-Number: K972118 · 1997-08-15

Decision Date1997-08-15

Product CodeEJH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

VERA PDN is the device name listed in this FDA 510(k) record. The listed applicant is Aalba Dent, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972118. 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 VERA PDN?

VERA PDN is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Aalba Dent, Inc.. The 510(k) number is K972118.

When did VERA PDN receive FDA 510(k) clearance?

VERA PDN received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972118.

Who is the listed applicant for VERA PDN?

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

What is the FDA product code for VERA PDN?

The FDA product code for VERA PDN is EJH.

Other records listing Aalba Dent, 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.

K040180CONTINUM V K040179CONTINUM K033356VERASOFT ES K982094VERABOND 2 K972971NPG + 2 K973265VERABOND 2V

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Related Devices (Code: EJH)

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO K040180CONTINUM 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.