Product Code: DZC FDA class 1 21 CFR 872.5410

Wire, Orthodontic

Dental

The Orthodontic Wire is a dental device made from metal alloy formed into an arch shape and seated in orthodontic brackets to apply continuous forces that guide tooth movement over the course of orthodontic treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZC and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.

View on FDA

510(k)s

FEI Numbers

168

Registration Numbers

168

Unique Applicants

Years Active

Basic Information

Product Code: DZC
Device Class: FDA class 1
Regulation Number: 872.5410
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K112640	HYPERELASTIC WIRE	Nov 16, 2011	Substantially Equivalent	Ormco Corp.
K943334	HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT	Oct 05, 1994	Substantially Equivalent	Jay H. Geller
K935638	NITINOL, NITI	May 18, 1994	Substantially Equivalent	Highland Metals
K935140	DENTAURUM STEEL LIGATURE WIRES	Feb 04, 1994	Substantially Equivalent	Dentauraum, Inc.
K935142	DENTAURUM WIRES	Jan 31, 1994	Substantially Equivalent	Dentauraum, Inc.
K934265	FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE	Jan 21, 1994	Substantially Equivalent	Flexmedics
K933374	NITI COIL SPRINGS	Nov 19, 1993	Substantially Equivalent	Highland Metals
K933377	STAINLESS STEEL ARCHES REPACKER RELABETER	Nov 16, 1993	Substantially Equivalent	Highland Metals
K933380	REVERSE SURVE NITI ARCH WIRE	Nov 12, 1993	Substantially Equivalent	Highland Metals
K933379	STAINLESS STEEL ARCHES	Nov 12, 1993	Substantially Equivalent	Highland Metals
K933378	REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER	Nov 12, 1993	Substantially Equivalent	Highland Metals
K933376	NITI ARCH WIRE ON A SPOOL	Nov 12, 1993	Substantially Equivalent	Highland Metals
K931631	COATED ORTHODONTIC DEVICES	Jul 28, 1993	Substantially Equivalent	Wonder Wire
K930202	TITAN SEPARATING SPRING	May 27, 1993	Substantially Equivalent	Ortho Spectrum, Inc.
K924805	ORTHODONTIC ARCH WIRE	Mar 31, 1993	Substantially Equivalent	Ultimate Wireforms, Inc.
K923837	DIMPLED MULTI MODULUS ARCH WIRE	Mar 31, 1993	Substantially Equivalent	Ultimate Wireforms, Inc.
K923836	.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING	Dec 23, 1992	Substantially Equivalent	Ultimate Wireforms, Inc.
K923838	THE ULTIMATE RCS ARCH WIRE	Dec 04, 1992	Substantially Equivalent	Ultimate Wireforms, Inc.
K920905	BIOFORCE WIRE	Nov 04, 1992	Substantially Equivalent	Gac Intl., Inc.
K923839	NITINOL GENTLE TOUCH COIL SPRING	Oct 15, 1992	Substantially Equivalent	Ultimate Wireforms, Inc.
K920850	GAC THUMB-SUCKING CONTROL APPLIANCE	Aug 24, 1992	Substantially Equivalent	Gac Intl., Inc.
K863742	FLEXMEDICS NITINOL ARCH WIRE	Nov 24, 1986	Substantially Equivalent	Flexmedics
K852975	INTERPORE 200 POROUS HYDROXYAPATITE	Oct 31, 1985	Substantially Equivalent	Inrterpore Intl.
K851878	A COMPANY BRASS SEPARATING RINGS	Jun 05, 1985	Substantially Equivalent	A Company, Inc.
K851055	SENTINOL -ORTHODONTIC ARCH WIRE	May 09, 1985	Substantially Equivalent	Gac Intl., Inc.
K843171	FILAFEX TM, ESTHETIC ORTHODONTIC WIRE	Dec 03, 1984	Substantially Equivalent	Berkley and Co.
K843722	ORTHODONTIC WIRE	Nov 09, 1984	Substantially Equivalent	Arthur L. Wool
K841638	ALINE ORTHODONTIC ARCHWIRE	Jun 27, 1984	Substantially Equivalent	A Company, Inc.
K833788	FILAFEX ESTHETIC ORTHODINIC WIRE	Jan 24, 1984	Substantially Equivalent	Berkley and Co.
K812454	PAC-AID	Sep 23, 1981	Substantially Equivalent	Albert J. Anthony, Dmd