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FDA 510(k)

DENTAURUM WIRES

K-Number: K935142 · 1994-01-31

ApplicantDentauraum, Inc.
Decision Date1994-01-31
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM WIRES is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-01-31 under 510(k) number K935142. The device is classified under product code DZC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAURUM WIRES?

DENTAURUM WIRES is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Dentauraum, Inc.. The 510(k) number is K935142.

When did DENTAURUM WIRES receive FDA 510(k) clearance?

DENTAURUM WIRES received FDA 510(k) clearance on 1994-01-31, under 510(k) number K935142.

Who is the listed applicant for DENTAURUM WIRES?

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 WIRES?

The FDA product code for DENTAURUM WIRES is DZC.

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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: DZC)

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.

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. GellerK935638NITINOL, NITIHighland MetalsK935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedicsK933374NITI COIL SPRINGSHighland Metals

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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