FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertex-Dental BV
DI: 08719425508184
·
Model: NOHKORBL01000
·
Vertex-Dental B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vertex-Dental BV
- Primary DI
- 08719425508184
- Version / Model
- NOHKORBL01000
- Company Name
- Vertex-Dental B.V.
- Labeler DUNS
- 406389056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-14
- Public Version
- 1
- Public Version Date
- 2018-04-16
- Public Version Status
- New
- Public Device Record Key
- 21160304-bb35-4bcc-8611-fb113bb6b84b
Device Description
NextDent Ortho Rigid / Blue
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBH | MATERIAL, IMPRESSION TRAY, RESIN | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43025 | Dental occlusal splint, custom-made | A rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719425508184 | GS1 |