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FDA 510(k)

FASCINATION CERAMIC BRACKET

K-Number: K935139 · 1994-02-04

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

Device Summary

FASCINATION CERAMIC BRACKET 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 K935139. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASCINATION CERAMIC BRACKET?

FASCINATION CERAMIC BRACKET 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 K935139.

When did FASCINATION CERAMIC BRACKET receive FDA 510(k) clearance?

FASCINATION CERAMIC BRACKET received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935139.

Who is the listed applicant for FASCINATION CERAMIC BRACKET?

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 FASCINATION CERAMIC BRACKET?

The FDA product code for FASCINATION CERAMIC BRACKET is EJF.

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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: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK936244REGENCY BRACKETMid-American Dental Specialties, 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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