FDA UDI
In Commercial Distribution
🇺🇸 United States
CeraRoot Implant System
DI: 08435453900157
·
Model: 340.010
·
CERAROOT SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CeraRoot Implant System
- Primary DI
- 08435453900157
- Version / Model
- 340.010
- Catalog Number
- 340.010
- Company Name
- CERAROOT SL.
- Labeler DUNS
- 467001948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-08
- Public Version
- 4
- Public Version Date
- 2019-07-01
- Public Version Status
- Update
- Public Device Record Key
- ce8b8d89-3993-438b-aebd-521e65cdc6f2
Device Description
Implant CeraRoot 34:10/4.1-4.8 Size L= 10mm Indicated for CANINES AND PREMOLARS SHORT ABUTMENT 4.3MM One-piece zirconia dental Implant including abutment.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435453900157 | GS1 |
Customer Contacts
- Phone
- +34937683962
- [email protected]
- Phone
- +18184504776
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093595 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius