DIO UF HSA Internal Sub-Merged Implant System
DIO UF HSA Internal Sub-Merged Implant System provides screw-type dental fixtures and restorative components. The fixture replaces a tooth root in the upper or lower jaw and connects to an…
DIO UF HSA Internal Sub-Merged Implant System provides screw-type dental fixtures and restorative components. The fixture replaces a tooth root in the upper or lower jaw and connects to an abutment through a tapered joint.
The fixtures are Grade 4 commercially pure titanium with a sandblasted, large-grit, acid-etched surface. Their diameters range from 3.8 to 7.0 mm and lengths from 7 to 16 mm.
Listed Item
The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
System Components and Use
The family includes dental implants, superstructures, prosthetic instruments and surgical instruments. Fixtures support single- or multiple-unit restorations in partially or fully edentulous jaws and can be used in one-stage or two-stage surgery. The fixture material does not define every restorative or instrument component.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K122519 |
| Record published | 2015-10-22 |
| Record revised | 2022-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2023-08-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UF(II) 5008S | Ø5.0X8.5mm | In distribution |
| UF(II) 5007S | Ø5.0X7mm | In distribution |
| UF(II) 5516S | Ø5.5X16mm | In distribution |
| UF(II) 4518S | Ø4.5X18mm | In distribution |
| UF(II) 5511S | Ø5.5X11.5mm | In distribution |
| UF(II) 4008S | Ø4.0X8.5mm | In distribution |
| UF(II) 5510S | Ø5.5X10mm | In distribution |
| UF(II) 5015S | Ø5.0X15mm | In distribution |
| UF(II) 4011S | Ø4.0X11.5mm | In distribution |
| UF(II) 5513S | Ø5.5X13mm | In distribution |
| UF(II) 5011S | Ø5.0X11.5mm | In distribution |
| UF(II) 4513S | Ø4.5X13mm | In distribution |
| UF(II) 4516S | Ø4.5X16mm | In distribution |
| UF(II) 4018S | Ø4.0X18mm | In distribution |
| UF(II) 5016S | Ø5.0X16mm | In distribution |
| UF(II) 4515S | Ø4.5X15mm | In distribution |
| UF(II) 5507S | Ø5.5X7mm | In distribution |
| UF(II) 4016S | Ø4.0X16mm | In distribution |
| UF(II) 4511S | Ø4.5X11.5mm | In distribution |
| UF(II) 4010S | Ø4.0X10mm | In distribution |
| UF(II) 4508S | Ø4.5X8.5mm | In distribution |
| UF(II) 5508S | Ø5.5X8.5mm | In distribution |
| UF(II) 4015S | Ø4.0X15mm | In distribution |
| UF(II) 5515S | Ø5.5X15mm | In distribution |
| UF(II) 5518S | Ø5.5X18mm | In distribution |
| UF(II) 4507S | Ø4.5X7mm | In distribution |
| UFIII 3816S | Ø3.8X16mm | In distribution |
| UF(II) 5018S | Ø5.0X18mm | In distribution |
| UF(II) 5013S | Ø5.0X13mm | In distribution |
| UF(II) 4013S | Ø4.0X13mm | In distribution |
| UF(II) 4510S | Ø4.5X10mm | In distribution |
| UF(II) 5010S | Ø5.0X10mm | In distribution |
| UF(II) 4513S | Ø4.5X13mm | Withdrawn |
| UF(II) 5010S | Ø5.0X10mm | Withdrawn |
| UF(II) 4518S | Ø4.5X18mm | Withdrawn |
| UF(II) 4516S | Ø4.5X16mm | Withdrawn |
| PUF(II) 5507S | Ø5.5X7mm | Withdrawn |
| UF(II) 5518S | Ø5.5X18mm | Withdrawn |
| UF 4510S | Ø4.5X10mm | Withdrawn |
| UF(II) 5013S | Ø5.0X13mm | Withdrawn |
| UF(II) 5510S | Ø5.5X10mm | Withdrawn |
| PSWF 7014S | Ø7.0X14mm | Withdrawn |
| UF 4507S | Ø4.5X7mm | Withdrawn |
| UF(II) 4015S | Ø4.0X15mm | Withdrawn |
| UF 4008S | Ø4.0X8.5mm | Withdrawn |
| UF 5010S | Ø5.0X10mm | Withdrawn |
| SWF 6510S | Ø6.5X10mm | Withdrawn |
| PUF(II) 4507S | Ø4.5X7mm | Withdrawn |
| SWF 7006S | Ø7.0X6mm | Withdrawn |
| UF(II) 5011S | Ø5.0X11.5mm | Withdrawn |
| SWF 6010S | Ø6.0X10mm | Withdrawn |
| UF 3815S | Ø3.8X15mm | Withdrawn |
| PUF(II) 5008S | Ø5.0X8.5mm | Withdrawn |
| PUF(II) 4515S | Ø4.5X15mm | Withdrawn |
| UF 3813S | Ø3.8X13mm | Withdrawn |
| UF 5016S | Ø5.0X16mm | Withdrawn |
| UF(II) 5515S | Ø5.5X15mm | Withdrawn |
| UF(II) 4008S | Ø4.0X8.5mm | Withdrawn |
| UF 3810S<VerA> | Ø3.8X10mm | Withdrawn |
| SWF 6508S | Ø6.5X8mm | Withdrawn |
| UF(II) 5511S | Ø5.5X11.5mm | Withdrawn |
| PUF(II) 5013S | Ø5.0X13mm | Withdrawn |
| PUF(II) 5513S | Ø5.5X13mm | Withdrawn |
| UF(II) 4011S | Ø4.0X11.5mm | Withdrawn |
| UF 4516S | Ø4.5X16mm | Withdrawn |
| UF(II) 4508S | Ø4.5X8.5mm | Withdrawn |
| UF 5007S | Ø5.0X7mm | Withdrawn |
| SWF 6514S | Ø6.5X14mm | Withdrawn |
| PUF(II) 4510S | Ø4.5X10mm | Withdrawn |
| UF(II) 5007S | Ø5.0X7mm | Withdrawn |
| UF 3816S | Ø3.8X16mm | Withdrawn |
| UF 4513S | Ø4.5X13mm | Withdrawn |
| PSWF 6506S | Ø6.5X6mm | Withdrawn |
| SWF 7014S | Ø7.0X14mm | Withdrawn |
| UF 4011S | Ø4.0X11.5mm | Withdrawn |
| UF(II) 5513S | Ø5.5X13mm | Withdrawn |
| UF(II) 5008S | Ø5.0X8.5mm | Withdrawn |
| PUF(II) 4511S | Ø4.5X11.5mm | Withdrawn |
| SWF 6014S | Ø6.0X14mm | Withdrawn |
| SWF 7010S | Ø7.0X10mm | Withdrawn |
| PSWF 6510S | Ø6.5X10mm | Withdrawn |
| PSWF 7006S | Ø7.0X6mm | Withdrawn |
| PSWF 6006S | Ø6.0X6mm | Withdrawn |
| PUF(II) 4513S | Ø4.5X13mm | Withdrawn |
| SWF 7008S | Ø7.0X8mm | Withdrawn |
| UF(II) 4010S | Ø4.0X10mm | Withdrawn |
| PUF(II) 5508S | Ø5.5X8.5mm | Withdrawn |
| SWF 6506S | Ø6.5X6mm | Withdrawn |
| UF(II) 4013S | Ø4.0X13mm | Withdrawn |
| UF 4007S | Ø4.0X7mm | Withdrawn |
| PSWF 6012S | Ø6.0X12mm | Withdrawn |
| UF 4511S | Ø4.5X11.5mm | Withdrawn |
| UF 4010S | Ø4.0X10mm | Withdrawn |
| UF 3811S | Ø3.8X11.5mm | Withdrawn |
| UF(II) 5015S | Ø5.0X15mm | Withdrawn |
| SWF 6012S | Ø6.0X12mm | Withdrawn |
| UF 4015S | Ø4.0X15mm | Withdrawn |
| UF(II) 5018S | Ø5.0X18mm | Withdrawn |
| UF(II) 4507S | Ø4.5X7mm | Withdrawn |
| UF(II) 4515S | Ø4.5X15mm | Withdrawn |
| PUF(II) 4015S | Ø4.0X15mm | Withdrawn |
| PSWF 7008S | Ø7.0X8mm | Withdrawn |
| UF(II) 4511S | Ø4.5X11.5mm | Withdrawn |
| PSWF 6008S | Ø6.0X8mm | Withdrawn |
| PSWF 6514S | Ø6.5X14mm | Withdrawn |
| UF 4013S | Ø4.0X13mm | Withdrawn |
| PUF(II) 5015S | Ø5.0X15mm | Withdrawn |
| PUF(II) 4011S | Ø4.0X11.5mm | Withdrawn |
| SWF 6512S | Ø6.5X12mm | Withdrawn |
| SWF 6008S | Ø6.0X8mm | Withdrawn |
| PUF(II) 4013S | Ø4.0X13mm | Withdrawn |
| PSWF 6010S | Ø6.0X10mm | Withdrawn |
| PUF(II) 5510S | Ø5.5X10mm | Withdrawn |
| UF(II) 4510S | Ø4.5X10mm | Withdrawn |
| PSWF 6508S | Ø6.5X8mm | Withdrawn |
| UF 3808S | Ø3.8X8.5mm | Withdrawn |
| UF 5011S | Ø5.0X11.5mm | Withdrawn |
| PUF(II) 4008S | Ø4.0X8.5mm | Withdrawn |
| PUF(II) 5007S | Ø5.0X7mm | Withdrawn |
| UF(II) 5508S | Ø5.5X8.5mm | Withdrawn |
| UF 5008S | Ø5.0X8.5mm | Withdrawn |
| UF(II) 4016S | Ø4.0X16mm | Withdrawn |
| PUF(II) 5011S | Ø5.0X11.5mm | Withdrawn |
| UF 4515S | Ø4.5X15mm | Withdrawn |
| UF 5015S | Ø5.0X15mm | Withdrawn |
| PUF(II) 5511S | Ø5.5X11.5mm | Withdrawn |
| PUF(II) 5515S | Ø5.5X15mm | Withdrawn |
| PSWF 6512S | Ø6.5X12mm | Withdrawn |
| PSWF 7010S | Ø7.0X10mm | Withdrawn |
| UF(II) 5016S | Ø5.0X16mm | Withdrawn |
| PSWF 6014S | Ø6.0X14mm | Withdrawn |
| PUF(II) 4010S | Ø4.0X10mm | Withdrawn |
| UF(II) 4018S | Ø4.0X18mm | Withdrawn |
| UF(II) 5516S | Ø5.5X16mm | Withdrawn |
| UF 4508S | Ø4.5X8.5mm | Withdrawn |
| SWF 7012S | Ø7.0X12mm | Withdrawn |
| UF 3810S | Ø3.8X10mm | Withdrawn |
| PUF(II) 5010S | Ø5.0X10mm | Withdrawn |
| SWF 6006S | Ø6.0X6mm | Withdrawn |
| UF(II) 5507S | Ø5.5X7mm | Withdrawn |
| PSWF 7012S | Ø7.0X12mm | Withdrawn |
| UF 5013S | Ø5.0X13mm | Withdrawn |
| UF 4016S | Ø4.0X16mm | Withdrawn |
| PUF(II) 4508S | Ø4.5X8.5mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182194 | 2018-12-14 |
| K173975 | 2018-06-01 |
| K170608 | 2018-03-30 |
| K161987 | 2017-02-21 |
| K122519 | 2013-05-21 |
| K112746 | 2011-10-21 |
| K100100 | 2010-11-10 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.