FDA UDI
In Commercial Distribution
🇺🇸 United States
Astek
DI: 00840326423882
·
Model: 19028
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Astek
- Primary DI
- 00840326423882
- Version / Model
- 19028
- Catalog Number
- 19028
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-17
- Public Version
- 1
- Public Version Date
- 2025-03-25
- Public Version Status
- New
- Public Device Record Key
- b181cfd8-173e-4005-b362-804b0ed41f8a
Device Description
Pro-Matrix Curve 6mm Wide Band
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JEP | Retainer, Matrix | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45008 | Dental matrix band tensioner | A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840326423889 | GS1 | Inner Pack | 20 | In Commercial Distribution | |
| Primary | 00840326423882 | GS1 | ||||
| Package | 20840326423886 | GS1 | Case | 60 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]