FDA UDI
In Commercial Distribution
🇺🇸 United States
Risas Reveal®
DI: 00190707105686
·
Model: 1NMBR041RI02T2000
·
ORTHO ORGANIZERS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
41
Basic Information
- Brand Name
- Risas Reveal®
- Primary DI
- 00190707105686
- Version / Model
- 1NMBR041RI02T2000
- Company Name
- ORTHO ORGANIZERS, INC.
- Labeler DUNS
- 062165188
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 41
- Record Status
- Published
- Publish Date
- 2024-01-17
- Public Version
- 1
- Public Version Date
- 2024-01-25
- Public Version Status
- New
- Public Device Record Key
- 87aaca17-ad5e-499b-bba9-39c632ff5e75
Device Description
Risas Reveal® Aligners STANDARD (41 Trays)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NXC | Aligner, sequential | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44738 | Orthodontic progressive aligner | A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10190707105683 | GS1 | ||||
| Primary | 00190707105686 | GS1 |