Identity
- Trade Name
- WINSIX Implant System: Extreme Abutment System FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Straight Abutment EA Ø 5.2 GH 4 mm FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- EA52004 FDA UDI
- Primary DI / UDI-DI
- 08051511803231 FDA UDI
- 510(k) Number
- K133733 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 4 Millimeter FDA UDIOuter Diameter — 5.2 Millimeter FDA UDI
Category: Dental implant system
WINSIX Implant System: Extreme Abutment System by Biosaf In Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K133733 also covers:
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
- WINSIX Implant System — BIOSAF IN SRL
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biosaf In Srl
Sources (1)
- FDA UDI 3534e001-87f0-4fe7-af00-285c292a2567 36 fields · synced Jun 1, 2026