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FDA 510(k)

VITALLIUM WIRE

K-Number: K872746 · 1987-07-21

ApplicantAustenal Dental, Inc.
Decision Date1987-07-21
Product CodeEJW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITALLIUM WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Austenal Dental, Inc.. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872746. The device is classified under product code EJW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALLIUM WIRE?

VITALLIUM WIRE is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K872746.

When did VITALLIUM WIRE receive FDA 510(k) clearance?

VITALLIUM WIRE received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872746.

Who is the listed applicant for VITALLIUM WIRE?

The FDA 510(k) record lists Austenal Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALLIUM WIRE?

The FDA product code for VITALLIUM WIRE is EJW.

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Other records listing Austenal Dental, 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.

K890713OVERDENTURE - STUD ATTACHMENTK883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINK880875VITALLIUM EQUIPOISE ALLOYK871849LIGHT CURE DENTURE GLAZEK863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIALK865025AUSTENAL CONDENSING INSTRUMENT

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Related Devices (Code: EJW)

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.

K901257WIRONTOM CLASP WIREIvoclar North America, Inc.K881331ORTHODONTIC NITINOL SPRINGSFlexmedics

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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