UF Implant System
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…
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. The Dental Implants, fixtures are made of commercial pure titanium, grade 4(ASTM F67) which have a S.L.A (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm)
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 | 2021-05-11 |
| Record revised | 2023-08-28 (version 4) |
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 | Special storage condition: tmperature limitation 1˚C ~ 30˚C, Humidity 80% |
| Distribution end date | 2023-08-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UF 4013S<VerA> | Ø4.0X13mm | Withdrawn |
| PSWF 6008S | ⓦ Ø6.0X8mm | Withdrawn |
| PUF(II) 4515S | ® Ø4.5X15mm | Withdrawn |
| UF(II) 4508S | ® Ø4.5X8.5mm | Withdrawn |
| UF 5007S | ® Ø5.0X7mm | Withdrawn |
| UF 4510S | ® Ø4.5X10mm | Withdrawn |
| UF 5008S | ® Ø5.0X8.5mm | Withdrawn |
| SWF 7010S | ⓦ Ø7.0X10mm | Withdrawn |
| UF 4010S | ® Ø4.0X10mm | Withdrawn |
| PSWF 7008S | ⓦ Ø7.0X8mm | Withdrawn |
| UF(II) 5513S | ® Ø5.5X13mm | Withdrawn |
| PUF(II) 5010S | ® Ø5.0X10mm | Withdrawn |
| UF 4507S<VerA> | Ø4.5X7mm | Withdrawn |
| PUF(II) 4508S | ® Ø4.5X8mm | Withdrawn |
| UF(II) 5015S | ® Ø5.0X15mm | Withdrawn |
| SWF 6012S | ⓦ Ø6.0X12mm | Withdrawn |
| SWF 6008S | ⓦ Ø6.0X8mm | Withdrawn |
| UF(II) 4510S | ® Ø4.5X10mm | Withdrawn |
| SWF 7012S | ⓦ Ø7.0X12mm | Withdrawn |
| UF 4516S | ® Ø4.5X16mm | Withdrawn |
| UF 3811S | ® Ø3.8X11.5mm | Withdrawn |
| UF 3808S | ® Ø3.8X8mm | Withdrawn |
| UF(II) 4008S | ® Ø4.0X8.5mm | Withdrawn |
| UF 4011S | ® Ø4.0X11.5mm | Withdrawn |
| UF(II) 5515S | ® Ø5.5X15mm | Withdrawn |
| UF 3811S<VerA> | Ø3.8X11.5mm | Withdrawn |
| UF(II) 4511S | ® Ø4.5X11.5mm | Withdrawn |
| PUF(II) 4013S | ® Ø4.0X13mm | Withdrawn |
| UF 4511S<VerA> | Ø4.5X11.5mm | Withdrawn |
| UF 4008S | ® Ø4.0X8.5mm | Withdrawn |
| UF 3813S<VerA> | Ø3.8X13mm | Withdrawn |
| PSWF 7012S | ⓦ Ø7.0X12mm | Withdrawn |
| UF(II) 5510S | ® Ø5.5X10mm | Withdrawn |
| SWF 6514S | ⓦ Ø6.5X14mm | Withdrawn |
| UF(II) 4516S | ® Ø4.5X16mm | Withdrawn |
| UF 4508S<VerA> | Ø4.5X8.5mm | Withdrawn |
| UF(II) 4518S | ® Ø4.5X18mm | Withdrawn |
| PSWF 7014S | ⓦ Ø7.0X14mm | Withdrawn |
| UF(II) 5511S | ® Ø5.5X11mm | Withdrawn |
| UF 4007S<VerA> | Ø4.0X7mm | Withdrawn |
| UF(II) 5016S | ® Ø5.0X16mm | Withdrawn |
| PSWF 6510S | ⓦ Ø6.5X10mm | Withdrawn |
| UF(II) 4016S | ® Ø4.0X16mm | Withdrawn |
| UF(II) 4515S | ® Ø4.5X15mm | Withdrawn |
| UF(II) 5013S | ® Ø5.0X13mm | Withdrawn |
| PSWF 6506S | ⓦ Ø6.5X6mm | Withdrawn |
| UF 4011S<VerA> | Ø4.0X11.5mm | Withdrawn |
| UF 3813S | ® Ø3.8X13mm | Withdrawn |
| PUF(II) 4011S | ® Ø4.0X11mm | Withdrawn |
| UF(II) 4013S | ® Ø4.0X13mm | Withdrawn |
| UF(II) 4011S | ® Ø4.0X11.5mm | Withdrawn |
| PUF(II) 5015S | ® Ø5.0X15mm | Withdrawn |
| PSWF 6006S | ⓦ Ø6.0X6mm | Withdrawn |
| PSWF 6514S | ⓦ Ø6.5X14mm | Withdrawn |
| UF 4513S<VerA> | Ø4.5X13mm | Withdrawn |
| UF 5015S | ® Ø5.0X15mm | Withdrawn |
| PSWF 6014S | ⓦ Ø6.0X14mm | Withdrawn |
| UF(II) 5518S | ® Ø5.5X16mm | Withdrawn |
| PUF(II) 5511S | ® Ø5.5X11mm | Withdrawn |
| PUF(II) 4513S | ® Ø4.5X13mm | Withdrawn |
| PSWF 6012S | ⓦ Ø6.0X12mm | Withdrawn |
| PUF(II) 5507S | ® Ø5.5X7mm | Withdrawn |
| SWF 6506S | ⓦ Ø6.5X6mm | Withdrawn |
| UF 5011S<VerA> | Ø5.0X11.5mm | Withdrawn |
| UF(II) 5011S | ® Ø5.0X11.5mm | Withdrawn |
| UF(II) 4513S | ® Ø4.5X13mm | Withdrawn |
| SWF 6508S | ⓦ Ø6.5X8mm | Withdrawn |
| UF 5013S<VerA> | Ø5.0X13mm | Withdrawn |
| PUF(II) 5013S | ® Ø5.0X13mm | Withdrawn |
| UF 3816S | ® Ø3.8X16mm | Withdrawn |
| PUF(II) 4510S | ® Ø4.5X10mm | Withdrawn |
| PUF(II) 5007S | ® Ø5.0X7mm | Withdrawn |
| SWF 6510S | ⓦ Ø6.5X10mm | Withdrawn |
| SWF 6014S | ⓦ Ø6.0X14mm | Withdrawn |
| UF(II) 5010S | ® Ø5.0X10mm | Withdrawn |
| PSWF 6010S | ⓦ Ø6.0X10mm | Withdrawn |
| UF 3808S<VerA> | Ø3.8X8.5mm | Withdrawn |
| SWF 7006S | ⓦ Ø7.0X6mm | Withdrawn |
| UF(II) 5516S | ® Ø5.5X16mm | Withdrawn |
| UF 4515S | ® Ø4.5X15mm | Withdrawn |
| UF 4010S<VerA> | Ø4.0X10mm | Withdrawn |
| PUF(II) 4015S | ® Ø4.0X15mm | Withdrawn |
| SWF 7008S | ⓦ Ø7.0X8mm | Withdrawn |
| UF(II) 4018S | ® Ø4.0X18mm | Withdrawn |
| UF(II) 5508S | ® Ø5.5X8mm | Withdrawn |
| UF 5008S<VerA> | Ø5.0X8.5mm | Withdrawn |
| PUF(II) 5011S | ® Ø5.0X11mm | Withdrawn |
| PUF(II) 4008S | ® Ø4.0X8mm | Withdrawn |
| UF 3810S | ® Ø3.8X10mm | Withdrawn |
| SWF 6010S | ⓦ Ø6.0X10mm | Withdrawn |
| UF 4510S<VerA> | Ø4.5X10mm | Withdrawn |
| UF 4015S | ® Ø4.0X15mm | Withdrawn |
| UF 4013S | ® Ø4.0X13mm | Withdrawn |
| SWF 7014S | ⓦ Ø7.0X14mm | Withdrawn |
| PSWF 6512S | ⓦ Ø6.5X12mm | Withdrawn |
| UF 4016S | ® Ø4.0X16mm | Withdrawn |
| PUF(II) 5008S | ® Ø5.0X8mm | Withdrawn |
| UF 5013S | ® Ø5.0X13mm | Withdrawn |
| PSWF 6508S | ⓦ Ø6.5X8mm | Withdrawn |
| UF 5010S<VerA> | Ø5.0X10mm | Withdrawn |
| SWF 6512S | ⓦ Ø6.5X12mm | Withdrawn |
| UF 4007S | ® Ø4.0X7mm | Withdrawn |
| PUF(II) 5515S | ® Ø5.5X15mm | Withdrawn |
| PUF(II) 4507S | ® Ø4.5X7mm | Withdrawn |
| PUF(II) 4511S | ® Ø4.5X11mm | Withdrawn |
| UF 3815S | ® Ø3.8X15mm | Withdrawn |
| PUF(II) 5513S | ® Ø5.5X13mm | Withdrawn |
| UF(II) 4010S | ® Ø4.0X10mm | Withdrawn |
| UF 5016S | ® Ø5.0X16mm | Withdrawn |
| UF 4507S | ® Ø4.5X7mm | Withdrawn |
| UF(II) 4015S | ® Ø4.0X15mm | Withdrawn |
| UF 5011S | ® Ø5.0X11.5mm | Withdrawn |
| PUF(II) 4010S | ® Ø4.0X10mm | Withdrawn |
| UF 4008S<VerA> | Ø4.0X8.5mm | Withdrawn |
| UF 4511S | ® Ø4.5X11.5mm | Withdrawn |
| PUF(II) 5510S | ® Ø5.5X10mm | Withdrawn |
| UF(II) 4507S | ® Ø4.5X7mm | Withdrawn |
| UF(II) 5008S | ® Ø5.0X8.5mm | Withdrawn |
| UF 4508S | ® Ø4.5X8.5mm | Withdrawn |
| UF(II) 5007S | ® Ø5.0X7mm | Withdrawn |
| UF 4513S | ® Ø4.5X13mm | Withdrawn |
| UF 5010S | ® Ø5.0X10mm | Withdrawn |
| UF(II) 5507S | ® Ø5.5X7mm | Withdrawn |
| SWF 6006S | ⓦ Ø6.0X6mm | Withdrawn |
| PSWF 7006S | ⓦ Ø7.0X6mm | Withdrawn |
| UF(II) 5018S | ® Ø5.0X18mm | Withdrawn |
| UF 5007S<VerA> | Ø5.0X7mm | Withdrawn |
| PUF(II) 5508S | ® Ø5.5X8mm | Withdrawn |
| PSWF 7010S | ⓦ Ø7.0X10mm | 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.