FDA UDI
In Commercial Distribution
🇺🇸 United States
CEREC Tessera
DI: EDD153654320650
·
Model: 5365432065
·
DeguDent GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEREC Tessera
- Primary DI
- EDD153654320650
- Version / Model
- 5365432065
- Catalog Number
- 5365432065
- Company Name
- DeguDent GmbH
- Labeler DUNS
- 329532225
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-05
- Public Version
- 1
- Public Version Date
- 2023-05-15
- Public Version Status
- New
- Public Device Record Key
- af1750ca-2865-4036-ab1d-d78a1a551547
Device Description
CEREC Tessera ABUTMENT LT B2 A16 S 3 PCS
Device Characteristics
- Single Use
- No
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NHA | Abutment, implant, dental, endosseous | Dental | 872.3630 | 2 |
| PNP | Dental abutment design software for dental laboratory | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) 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 | EDD153654320650 | HIBCC |