FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DD Bio Splint P
DI: EDDIK101151
·
Model: 98H15
·
Dental Direkt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DD Bio Splint P
- Primary DI
- EDDIK101151
- Version / Model
- 98H15
- Catalog Number
- K10115
- Company Name
- Dental Direkt GmbH
- Labeler DUNS
- 313214171
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-05
- Public Version
- 4
- Public Version Date
- 2023-07-11
- Public Version Status
- Update
- Public Device Record Key
- c40b6755-c27d-4600-939e-ced97dd1d1f3
- Distribution End Date
- 2023-07-09
Device Description
DD Bio Splint P are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints, bite regulators and drilling templates for long-term application in the oral cavity up to 12 months.
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
- No
- 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 |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
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 | EDDIK101151 | HIBCC |
Customer Contacts
- Phone
- +495225863190
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 98.5 | Millimeter | |
| Height | 15 | Millimeter |