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 |
| K933376 | NITI ARCH WIRE ON A SPOOL | Highland Metals | 1993-11-12 |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Highland Metals | 1993-11-12 |
| K933379 | STAINLESS STEEL ARCHES | 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 |
|---|---|---|---|
| 00840456209516 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209653 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209646 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209639 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209622 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209615 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209608 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209592 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209585 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209578 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209561 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209554 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209547 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209530 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209523 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209363 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209509 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209493 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209486 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209479 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209462 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209455 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209448 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209431 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209424 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209417 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209400 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209394 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209387 | JMU | JMU DENTAL, INC | 2026-06-24 |
| 00840456209370 | JMU | JMU DENTAL, INC | 2026-06-24 |