FDA UDI
In Commercial Distribution
🇺🇸 United States
CediTEC DB
DI: EDDI61971
·
Model: Disc orange-pink 30 mm
·
Dental Direkt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CediTEC DB
- Primary DI
- EDDI61971
- Version / Model
- Disc orange-pink 30 mm
- Catalog Number
- 6197
- Company Name
- Dental Direkt GmbH
- Labeler DUNS
- 313214171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-21
- Public Version
- 2
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- dcfdc433-b925-4956-bdb2-cd5d0e16644f
Device Description
CediTEC DB polymer milling blanks are intended for the fabrication of restorations.
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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 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 | EDDI61971 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230410 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 30 | Millimeter | |
| Outer Diameter | 98.5 | Millimeter |