FDA UDI
In Commercial Distribution
🇺🇸 United States
Vero
DI: 00190746202834
·
Model: 909-040816
·
AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vero
- Primary DI
- 00190746202834
- Version / Model
- 909-040816
- Catalog Number
- 909-040816
- Company Name
- AMERICAN ORTHODONTICS CORPORATION
- Labeler DUNS
- 044668515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-31
- Public Version
- 1
- Public Version Date
- 2026-04-08
- Public Version Status
- New
- Public Device Record Key
- bc49f90c-d69a-4cd5-8948-5e18c0505d35
Device Description
SUPPLIES VERO THERMOFORMING MATERIAL .030 5 in. Sq 20/PK
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KMY | POSITIONER, TOOTH, PREFORMED | Dental | 872.5525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190746202834 | GS1 |
Customer Contacts
- Phone
- +1(800)558-7687
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 6 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Light, Keep Dry