FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit
DI: 00652221153586
·
Model: 504-101
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit
- Primary DI
- 00652221153586
- Version / Model
- 504-101
- Catalog Number
- 504-101
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 3
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 8e332b5a-0049-4dea-988d-184452f95a12
Device Description
Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Radiation Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 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 | 00652221153586 | GS1 |
Customer Contacts
- Phone
- +1(800)423-4588
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Millimeter | |
| Length | 8 | Millimeter | |
| Length | 6 | Millimeter |