FDA UDI
In Commercial Distribution
🇺🇸 United States
CeraRoot Implant System
DI: 08435453900454
·
Model: 005.017
·
CERAROOT SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CeraRoot Implant System
- Primary DI
- 08435453900454
- Version / Model
- 005.017
- Catalog Number
- 005.017
- Company Name
- CERAROOT SL.
- Labeler DUNS
- 467001948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-14
- Public Version
- 1
- Public Version Date
- 2019-09-23
- Public Version Status
- New
- Public Device Record Key
- 32c43844-f169-40b9-85ea-7a809d6c223d
Device Description
Transporter 16 Short - steel for the CeraRoot 16 implant
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435453900454 | GS1 |
Customer Contacts
- Phone
- +18184504776
- [email protected]
- Phone
- +34937683962
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093595 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter |