Product code DYT
- Device name
- Maintainer, Space Preformed, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5525
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D175H3DMTA91 | MemoryTech Aligners | Hype Align Clear Orthodontics Limitada | 2026-02-10 |
| 00816063023777 | Invisalign Specifix Attachment System | Align Technology, Inc. | 2026-02-09 |
| 00816063023784 | lnvisalign Specifix Attachment System (include Engagement Features) | Align Technology, Inc. | 2026-02-09 |
| 08800062100043 | ODS Clear Resin - Retainer | ODS Co., Ltd. | 2025-01-13 |
| 00190707105525 | Reveal® | Ortho Organizers, Inc. | 2024-01-16 |
| 00190707105549 | Reveal® | Ortho Organizers, Inc. | 2024-01-16 |
| 00190707105556 | Reveal® | Ortho Organizers, Inc. | 2024-01-16 |
| D788GCOAVS2841 | Taglus | Gc Orthodontics America Inc. | 2023-01-25 |
| D788GCOAVS2801 | Taglus | Gc Orthodontics America Inc. | 2023-01-25 |
| D82852000100 | Incisor Blocks | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2023-01-03 |
| D82856000250 | TPA/Nance Combo | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82854001640 | EZ Bond - Lower | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82854001630 | EZ Bond - Upper | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82854001620 | Transfer Tray | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82853002400 | Transpalatal Arch | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82853001910 | Lingual Arch W/Omega | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82853001810 | Removable Lingual Arch | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82853001710 | Lower Lingual Arch | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D82853001620 | Upper Lingual Arch | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2022-12-12 |
| D788GCOAVS3621 | Taglus | Gc Orthodontics America Inc. | 2022-04-29 |
| D788GCOAVS3581 | Taglus | Gc Orthodontics America Inc. | 2022-04-29 |
| D788GCOAVS3531 | Taglus | Gc Orthodontics America Inc. | 2022-04-29 |
| D788GCOAVS3521 | Taglus | Gc Orthodontics America Inc. | 2022-04-29 |
| D788GCOAVS0211 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0121 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0191 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0981 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0281 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0231 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |
| D788GCOAVS0221 | Taglus | Gc Orthodontics America Inc. | 2022-02-18 |