FDA UDI
In Commercial Distribution
🇺🇸 United States
ATOZ Mini-Screw
DI: 08800197900297
·
Model: MKS-1613
·
MK Meditech Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATOZ Mini-Screw
- Primary DI
- 08800197900297
- Version / Model
- MKS-1613
- Company Name
- MK Meditech Inc.
- Labeler DUNS
- 695009476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 2
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- e878fb77-de28-470b-86f9-09631a8c877a
Device Description
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 08800197900297 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210559 | 000 |