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FDA 510(k)

REMANIUM: CS & G-SOFT

K-Number: K952870 · 1995-07-27

ApplicantDentauraum, Inc.
Decision Date1995-07-27
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMANIUM: CS & G-SOFT 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 K952870. 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: CS & G-SOFT?

REMANIUM: CS & G-SOFT 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 K952870.

When did REMANIUM: CS & G-SOFT receive FDA 510(k) clearance?

REMANIUM: CS & G-SOFT received FDA 510(k) clearance on 1995-07-27, under 510(k) number K952870.

Who is the listed applicant for REMANIUM: CS & G-SOFT?

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: CS & G-SOFT?

The FDA product code for REMANIUM: CS & G-SOFT is EJH.

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Other records listing Dentauraum, 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.

K952867REMANIUM:GM 700, GM 380, GM 800, GFHK952866REMATITAN TITANIUMK952865REMANIUM: 200,CS, 380, AND CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942667DENT-O-CRYL ORTHODONTIC ACRYLICK942666ORTHALGENAT IMPRESSION MATERIAL

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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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