ECLIPSE PASSIVE
- Primary DI
- D90946300111
- Brand
- ECLIPSE PASSIVE
- Company
- Ortho Arch Company Inc
- Model
- 463-001
- Catalog number
- 463-001
- Device description
- 018 U1R ECLIPSE PASSIVE SLB ROTH +12T (5)
- Published
- 2023-06-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| ECQ | Aligner, Bracket, Orthodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ECQ | Aligner, Bracket, Orthodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D90946300111 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Self-ligating orthodontic bracket | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 020956330
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D90927010916 | ORTHO ARCH | 270-109 | 2025-09-29 | |
| D90927021918 | ORTHO ARCH | 270-219 | 2025-09-29 | |
| D90943001914 | ORTHO ARCH | 430-019 | 2025-09-29 | |
| D9094300201 | ORTHO ARCH | 430-020 | 2025-09-29 | |
| D90992402115 | ORTHO ARCH | 924-021 | 2025-09-29 | |
| D90992402216 | ORTHO ARCH | 924-022 | 2025-09-29 | |
| D909924023G1 | ORTHO ARCH | 924-023G | 2025-09-29 | |
| D909924024G1 | ORTHO ARCH | 924-024G | 2025-09-29 | |
| D909924033F1 | ORTHO ARCH | 924-033F | 2025-09-29 | |
| D909924034F1 | ORTHO ARCH | 924-034F | 2025-09-29 | |
| D909924043F1 | ORTHO ARCH | 924-043F | 2025-09-29 | |
| D909924044F1 | ORTHO ARCH | 924-044F | 2025-09-29 | |
| D90992412116 | ORTHO ARCH | 924-121 | 2025-09-29 | |
| D90992412217 | ORTHO ARCH | 924-122 | 2025-09-29 | |
| D909924123G1 | ORTHO ARCH | 924-123G | 2025-09-29 | |
| D909924124G1 | ORTHO ARCH | 924-124G | 2025-09-29 | |
| D909924133F1 | ORTHO ARCH | 924-133F | 2025-09-29 | |
| D909924134F1 | ORTHO ARCH | 924-134F | 2025-09-29 | |
| D909924141F1 | ORTHO ARCH | 924-141F | 2025-09-29 | |
| D909924142F1 | ORTHO ARCH | 924-142F | 2025-09-29 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G859PT20260010 | Clear Moves Aligner | CLEAR MOVES ALIGNERS | ECQ | 2026-05-22 |
| D90970000913 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D9097000111 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D9097001011 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D9097001021 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970010M1 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D9097001111 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970011511 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970011713 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D909700117L1 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970011814 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970011915 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D909700119S1 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970012310 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| D90970013210 | ORTHO ARCH | Ortho Arch Company Inc | ECQ | 2025-08-28 |
| 00371347018332 | Advance Dental Products | The Atlanta Dental Supply Company | ECQ | 2025-01-02 |
| 00371347018349 | Advance Dental Products | The Atlanta Dental Supply Company | ECQ | 2025-01-02 |
| 00723896026847 | SMILEGOODS ALIGNER CHEWIES MINT 24 PACK | PRACTICON, INC. | ECQ | 2024-08-07 |
| 00723896026854 | SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACK | PRACTICON, INC. | ECQ | 2024-08-07 |
| 00723896026878 | SMILEGOODS ALIGNER CHEWIES MINT | PRACTICON, INC. | ECQ | 2024-08-07 |
| 00723896026885 | SMILEGOODS ALIGNER CHEWIES UNSCENTED | PRACTICON, INC. | ECQ | 2024-08-07 |
| 00723896026892 | SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACK | PRACTICON, INC. | ECQ | 2024-08-07 |
| 00723896026908 | SMILEGOODS ALIGNER CHEWIES ASSORTED | PRACTICON, INC. | ECQ | 2024-08-07 |
| D90946161116 | ECLIPSE INTERACTIVE | Ortho Arch Company Inc | ECQ | 2023-06-14 |
| D909270106103 | LINGUAL BUTTON | Ortho Arch Company Inc | ECQ | 2023-06-13 |
| D90927010613 | WELDABLE LINGUAL BUTTONS | Ortho Arch Company Inc | ECQ | 2023-06-13 |
| D90927020210 | DIRECT BOND BUTTON | Ortho Arch Company Inc | ECQ | 2023-06-13 |
| D90927020311 | DIRECT BOND | Ortho Arch Company Inc | ECQ | 2023-06-13 |
| D90927020412 | COMPOSITE DIRECT BOND | Ortho Arch Company Inc | ECQ | 2023-06-13 |
| D90927020513 | DIRECT BOND TONGUE | Ortho Arch Company Inc | ECQ | 2023-06-13 |