Product code DYJ
- Device name
- Retainer, Screw Expansion, 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 |
|---|---|---|---|
| K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | Cleft Palate Appliances, Inc. | 1997-04-23 |
| K935154 | DENTAURUM EXPANSION SCREWS | Dentauraum, Inc. | 1994-02-03 |
| K925088 | EXPANSION SCREWS | Forestadent | 1993-05-22 |
| K912417 | MOLAR DISTALIZING ASSEMBLY | American Orthodontics | 1991-12-20 |
| K843705 | MANDIBULATOR JAW POSITIONER | A Company, Inc. | 1984-11-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033707104513 | LEONE SPA | LEONE SPA | 2026-05-28 |
| 08033707104834 | LEONE SPA | LEONE SPA | 2026-04-01 |
| 08033707104827 | LEONE SPA | LEONE SPA | 2026-04-01 |
| 08800197901621 | ATOZ Key | MK Meditech Inc. | 2025-11-03 |
| J011430120410 | prime4me® | DENTAURUM GmbH & Co.KG | 2025-10-09 |
| J011430120310 | prime4me® | DENTAURUM GmbH & Co.KG | 2025-10-09 |
| 07895742296612 | Morelli | Dental Morelli Ltda | 2025-09-10 |
| 07895742296643 | Morelli | Dental Morelli Ltda | 2025-09-10 |
| 07895742296636 | Morelli | Dental Morelli Ltda | 2025-09-10 |
| 07895742296629 | Morelli | Dental Morelli Ltda | 2025-09-10 |
| J011430120400 | prime4me® | DENTAURUM GmbH & Co.KG | 2025-07-10 |
| 07908611204332 | ICERAM CLEAR DISTALIZER | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-01-10 |
| J011602819330 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602819320 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602815330 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602815320 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602809330 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602809320 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602806330 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602806320 | N.A. | DENTAURUM GmbH & Co.KG | 2021-12-04 |
| J011602809010 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602808010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602810010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602811010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602812010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602815010 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602806010 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602819010 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602801010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011602800010 | palex® | DENTAURUM GmbH & Co.KG | 2016-09-15 |