Product code DZC
- Device name
- Wire, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5410
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112640 | HYPERELASTIC WIRE | Ormco Corp. | 2011-11-16 |
| K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | Jay H. Geller | 1994-10-05 |
| K935638 | NITINOL, NITI | Highland Metals | 1994-05-18 |
| K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. | 1994-02-04 |
| K935142 | DENTAURUM WIRES | Dentauraum, Inc. | 1994-01-31 |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Flexmedics | 1994-01-21 |
| K933374 | NITI COIL SPRINGS | Highland Metals | 1993-11-19 |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | Highland Metals | 1993-11-16 |
| K933379 | STAINLESS STEEL ARCHES | Highland Metals | 1993-11-12 |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Highland Metals | 1993-11-12 |
| K933376 | NITI ARCH WIRE ON A SPOOL | Highland Metals | 1993-11-12 |
| K933380 | REVERSE SURVE NITI ARCH WIRE | Highland Metals | 1993-11-12 |
| K931631 | COATED ORTHODONTIC DEVICES | Wonder Wire | 1993-07-28 |
| K930202 | TITAN SEPARATING SPRING | Ortho Spectrum, Inc. | 1993-05-27 |
| K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Ultimate Wireforms, Inc. | 1993-03-31 |
| K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. | 1993-03-31 |
| K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | Ultimate Wireforms, Inc. | 1992-12-23 |
| K923838 | THE ULTIMATE RCS ARCH WIRE | Ultimate Wireforms, Inc. | 1992-12-04 |
| K920905 | BIOFORCE WIRE | Gac Intl., Inc. | 1992-11-04 |
| K923839 | NITINOL GENTLE TOUCH COIL SPRING | Ultimate Wireforms, Inc. | 1992-10-15 |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | Gac Intl., Inc. | 1992-08-24 |
| K863742 | FLEXMEDICS NITINOL ARCH WIRE | Flexmedics | 1986-11-24 |
| K852975 | INTERPORE 200 POROUS HYDROXYAPATITE | Inrterpore Intl. | 1985-10-31 |
| K851878 | A COMPANY BRASS SEPARATING RINGS | A Company, Inc. | 1985-06-05 |
| K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | Gac Intl., Inc. | 1985-05-09 |
| K843171 | FILAFEX TM, ESTHETIC ORTHODONTIC WIRE | Berkley and Co. | 1984-12-03 |
| K843722 | ORTHODONTIC WIRE | Arthur L. Wool | 1984-11-09 |
| K841638 | ALINE ORTHODONTIC ARCHWIRE | A Company, Inc. | 1984-06-27 |
| K833788 | FILAFEX ESTHETIC ORTHODINIC WIRE | Berkley and Co. | 1984-01-24 |
| K812454 | PAC-AID | Albert J. Anthony, Dmd | 1981-09-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07908611211231 | STRAIGHT WIRE SS COLBOLOY 0.016X0.022 - RECTANGULAR - 10UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07898488900621 | KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENS | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216441 | NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.021X0.025 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216434 | NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.019X0.025 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216427 | NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.018X0.025 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216410 | NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.017X0.025 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216403 | NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.016X0.022 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216397 | NEW EUROPA I - SS OVOID SQUARE WIRE 0.016X0.016 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216380 | NEW EUROPA I - SS ROUND OVOID WIRE 0.020 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216373 | NEW EUROPA I - SS ROUND OVOID WIRE 0.018 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611216366 | NEW EUROPA I - SS ROUND OVOID WIRE 0.016 LOWER-10 UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
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| 07895742161330 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161323 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161316 | Morelli | Dental Morelli Ltda | 2021-04-30 |
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| 07895742161286 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161279 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161262 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161255 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161248 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161231 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161224 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161217 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161200 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742161194 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742151591 | Morelli | Dental Morelli Ltda | 2021-04-30 |