DZC · Wire, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | DZC |
|---|---|
| Device Name | Wire, Orthodontic |
| Regulation | 21 CFR 872.5410 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Cleared Devices (30)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112640 | HYPERELASTIC WIRE | Ormco Corp. | Nov 16, 2011 | SESE |
| K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | Jay H. Geller | Oct 5, 1994 | SESE |
| K935638 | NITINOL, NITI | Highland Metals | May 18, 1994 | SESE |
| K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. | Feb 4, 1994 | SESE |
| K935142 | DENTAURUM WIRES | Dentauraum, Inc. | Jan 31, 1994 | SESE |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Flexmedics | Jan 21, 1994 | SESE |
| K933374 | NITI COIL SPRINGS | Highland Metals | Nov 19, 1993 | SESE |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | Highland Metals | Nov 16, 1993 | SESE |
| K933380 | REVERSE SURVE NITI ARCH WIRE | Highland Metals | Nov 12, 1993 | SESE |
| K933379 | STAINLESS STEEL ARCHES | Highland Metals | Nov 12, 1993 | SESE |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Highland Metals | Nov 12, 1993 | SESE |
| K933376 | NITI ARCH WIRE ON A SPOOL | Highland Metals | Nov 12, 1993 | SESE |
| K931631 | COATED ORTHODONTIC DEVICES | Wonder Wire | Jul 28, 1993 | SESE |
| K930202 | TITAN SEPARATING SPRING | Ortho Spectrum, Inc. | May 27, 1993 | SESE |
| K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. | Mar 31, 1993 | SESE |
| K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Ultimate Wireforms, Inc. | Mar 31, 1993 | SESE |
| K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | Ultimate Wireforms, Inc. | Dec 23, 1992 | SESE |
| K923838 | THE ULTIMATE RCS ARCH WIRE | Ultimate Wireforms, Inc. | Dec 4, 1992 | SESE |
| K920905 | BIOFORCE WIRE | Gac Intl., Inc. | Nov 4, 1992 | SESE |
| K923839 | NITINOL GENTLE TOUCH COIL SPRING | Ultimate Wireforms, Inc. | Oct 15, 1992 | SESE |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | Gac Intl., Inc. | Aug 24, 1992 | SESE |
| K863742 | FLEXMEDICS NITINOL ARCH WIRE | Flexmedics | Nov 24, 1986 | SESE |
| K852975 | INTERPORE 200 POROUS HYDROXYAPATITE | Inrterpore Intl. | Oct 31, 1985 | SESE |
| K851878 | A COMPANY BRASS SEPARATING RINGS | A Company, Inc. | Jun 5, 1985 | SESE |
| K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | Gac Intl., Inc. | May 9, 1985 | SESE |
| K843171 | FILAFEX TM, ESTHETIC ORTHODONTIC WIRE | Berkley and Co. | Dec 3, 1984 | SESE |
| K843722 | ORTHODONTIC WIRE | Arthur L. Wool | Nov 9, 1984 | SESE |
| K841638 | ALINE ORTHODONTIC ARCHWIRE | A Company, Inc. | Jun 27, 1984 | SESE |
| K833788 | FILAFEX ESTHETIC ORTHODINIC WIRE | Berkley and Co. | Jan 24, 1984 | SESE |
| K812454 | PAC-AID | Albert J. Anthony, Dmd | Sep 23, 1981 | SESE |
Top Applicants
- Highland Metals — 7 clearances
- Ultimate Wireforms, Inc. — 5 clearances
- Gac Intl., Inc. — 3 clearances
- Flexmedics — 2 clearances
- Dentauraum, Inc. — 2 clearances
