FDA UDI
In Commercial Distribution
🇺🇸 United States
WINSIX Implant System: Flat Shift System
DI: 08051511802487
·
Model: Flat Shift Abutment Ø 4.5 GH 3mm for internal hex connection
·
BIOSAF IN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WINSIX Implant System: Flat Shift System
- Primary DI
- 08051511802487
- Version / Model
- Flat Shift Abutment Ø 4.5 GH 3mm for internal hex connection
- Catalog Number
- MFS453
- Company Name
- BIOSAF IN SRL
- Labeler DUNS
- 428657609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8a38ae37-f28c-41a2-bfa1-d83daddd37de
Device Description
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation.
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
- 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 | 08051511802487 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133733 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 3 | Millimeter | |
| Outer Diameter | 4.5 | Millimeter |