FDA UDI
In Commercial Distribution
🇺🇸 United States
Infinitas Orthodontic Mini Implant
DI: 05060429400091
·
Model: Infinitas M/I L9mm, D2.0mm, N2.5mm
·
DB ORTHODONTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Infinitas Orthodontic Mini Implant
- Primary DI
- 05060429400091
- Version / Model
- Infinitas M/I L9mm, D2.0mm, N2.5mm
- Catalog Number
- DB10-0016
- Company Name
- DB ORTHODONTICS LIMITED
- Labeler DUNS
- 213136229
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 4
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- aa5d1ecb-b9dc-4726-9cb7-cfd935816130
Device Description
Infinitas Orthodontic Mini Implant L9mm, D2.0mm Long Neck - Sterile
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46536 | Orthodontic anchoring screw | A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060429400091 | GS1 |
Customer Contacts
- Phone
- +441535650571
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.0 | Millimeter | |
| Length | 9 | Millimeter |