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FDA 510(k)

DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS

K-Number: K935144 · 1994-02-04

ApplicantDentauraum, Inc.
Decision Date1994-02-04
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-02-04 under 510(k) number K935144. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS?

DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Dentauraum, Inc.. The 510(k) number is K935144.

When did DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS receive FDA 510(k) clearance?

DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935144.

Who is the listed applicant for DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS?

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 OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS?

The FDA product code for DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS is ECI.

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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

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Related Devices (Code: ECI)

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.

K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.K980053GLENROE CHAINGlenroe TechnologiesK973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, 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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