FDA 510(k)

NITI ARCH WIRE ON A SPOOL

K-Number: K933376 · 1993-11-12

Decision Date1993-11-12

Product CodeDZC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NITI ARCH WIRE ON A SPOOL is the device name listed in this FDA 510(k) record. The listed applicant is Highland Metals. It received FDA 510(k) clearance on 1993-11-12 under 510(k) number K933376. 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 NITI ARCH WIRE ON A SPOOL?

NITI ARCH WIRE ON A SPOOL is a medical device that received FDA 510(k) clearance on 1993-11-12. The listed applicant is Highland Metals. The 510(k) number is K933376.

When did NITI ARCH WIRE ON A SPOOL receive FDA 510(k) clearance?

NITI ARCH WIRE ON A SPOOL received FDA 510(k) clearance on 1993-11-12, under 510(k) number K933376.

Who is the listed applicant for NITI ARCH WIRE ON A SPOOL?

The FDA 510(k) record lists Highland Metals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITI ARCH WIRE ON A SPOOL?

The FDA product code for NITI ARCH WIRE ON A SPOOL is DZC.

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Other records listing Highland Metals as applicant

K935638NITINOL, NITI K933374NITI COIL SPRINGS K933377STAINLESS STEEL ARCHES REPACKER RELABETER K933379STAINLESS STEEL ARCHES K933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER K933380REVERSE SURVE NITI ARCH WIRE

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Related Devices (Code: DZC)

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. Geller K935638NITINOL, NITIHighland Metals K935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K935142DENTAURUM WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedics

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.