FDA UDI
In Commercial Distribution
🇺🇸 United States
3Delta Crown
DI: EDEL16112350
·
Model: 1611235
·
DeltaMed GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3Delta Crown
- Primary DI
- EDEL16112350
- Version / Model
- 1611235
- Catalog Number
- 1611235
- Company Name
- DeltaMed GmbH
- Labeler DUNS
- 344805101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-11
- Public Version
- 1
- Public Version Date
- 2022-02-21
- Public Version Status
- New
- Public Device Record Key
- 25e5eb4f-37da-4c2c-9b81-33f23405a0af
Device Description
3Delta Crown A3.5 1000g
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
- 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62817 | Dental appliance fabrication material, combination-material | A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDEL16112350 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211804 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- avoid direct sunlight