FDA UDI
In Commercial Distribution
🇺🇸 United States
JDEvolution Plus
DI: 08055510170653
·
Model: 30º Conical Abutment Angulated H 2.5 JDEvolution Plus
·
J DENTAL CARE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- JDEvolution Plus
- Primary DI
- 08055510170653
- Version / Model
- 30º Conical Abutment Angulated H 2.5 JDEvolution Plus
- Catalog Number
- EVCA3025C:
- Company Name
- J DENTAL CARE SRL
- Labeler DUNS
- 428716597
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-31
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- a2db59f2-e13d-49ee-add8-7cb7db4bc9c0
Device Description
30º Conical Abutment Angulated H 2.5 JDEvolution Plus
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
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 | 08055510170653 | GS1 |
Customer Contacts
- Phone
- +39059454255
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143142 | 000 |