WINSIX Implant System: Counterbore healing screw internal hex connection

FDA UDI

Class II (US FDA UDI)

by Biosaf In Srl

Identity

Trade Name: WINSIX Implant System: Counterbore healing screw internal hex connection 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. Healing screws are used to cover the fixtures and to model the mucosa during her healing. FDA UDI
Model / Reference: counterbore healing screw Ø 5.2 H 5 mm for internal hex connection 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. Healing screws are used to cover the fixtures and to model the mucosa during her healing. FDA UDI

Identifiers

Catalog Number: VG524 FDA UDI
Primary DI / UDI-DI: 08051511801435 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 5 Millimeter FDA UDI
Outer Diameter — 5.2 Millimeter FDA UDI

Category: Dental implant system

WINSIX Implant System: Counterbore healing screw internal hex connection by Biosaf In Srl — Class II — FDA UDI — listed in FDA GUDID

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

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 397a881a-0ca9-4e66-9fb0-e72b114c7ef3 36 fields · synced May 31, 2026