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FDA 510(k)

DENTAURUM SPACE MAINTAINER

K-Number: K935856 · 1994-04-28

ApplicantDentauraum, Inc.
Decision Date1994-04-28
Product CodeDYT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM SPACE MAINTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-04-28 under 510(k) number K935856. The device is classified under product code DYT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAURUM SPACE MAINTAINER?

DENTAURUM SPACE MAINTAINER is a medical device that received FDA 510(k) clearance on 1994-04-28. The listed applicant is Dentauraum, Inc.. The 510(k) number is K935856.

When did DENTAURUM SPACE MAINTAINER receive FDA 510(k) clearance?

DENTAURUM SPACE MAINTAINER received FDA 510(k) clearance on 1994-04-28, under 510(k) number K935856.

Who is the listed applicant for DENTAURUM SPACE MAINTAINER?

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 DENTAURUM SPACE MAINTAINER?

The FDA product code for DENTAURUM SPACE MAINTAINER is DYT.

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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 TITANIUMK952870REMANIUM: CS & G-SOFTK952865REMANIUM: 200,CS, 380, AND CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942667DENT-O-CRYL ORTHODONTIC ACRYLIC

View all 24 devices →

Related Devices (Code: DYT)

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.

K864376FIBERBONDDentec, Inc.K812239UNITEK PALATAL BARUnitek Corp.K780814SAFETY STOP NECKSTRAPNorthwest Orthodontics, Inc.

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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