FDA 510(k)

REMANIUM:GM 700, GM 380, GM 800, GFH

K-Number: K952867 · 1995-07-27

Decision Date1995-07-27

Product CodeEJH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

REMANIUM:GM 700, GM 380, GM 800, GFH is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1995-07-27 under 510(k) number K952867. 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 REMANIUM:GM 700, GM 380, GM 800, GFH?

REMANIUM:GM 700, GM 380, GM 800, GFH is a medical device that received FDA 510(k) clearance on 1995-07-27. The listed applicant is Dentauraum, Inc.. The 510(k) number is K952867.

When did REMANIUM:GM 700, GM 380, GM 800, GFH receive FDA 510(k) clearance?

REMANIUM:GM 700, GM 380, GM 800, GFH received FDA 510(k) clearance on 1995-07-27, under 510(k) number K952867.

Who is the listed applicant for REMANIUM:GM 700, GM 380, GM 800, GFH?

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

What is the FDA product code for REMANIUM:GM 700, GM 380, GM 800, GFH?

The FDA product code for REMANIUM:GM 700, GM 380, GM 800, GFH is EJH.

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Other records listing Dentauraum, Inc. as applicant

K952866REMATITAN TITANIUM K952870REMANIUM: CS & G-SOFT K952865REMANIUM: 200,CS, 380, AND CD K952868DENTAURUM JACKET CROWN & ROOT POSTS K942667DENT-O-CRYL ORTHODONTIC ACRYLIC K942666ORTHALGENAT IMPRESSION MATERIAL

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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

View on FDA Database →

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