Ufiii Fixture
Ø5.0X11.5mm
7manufacturers in China registered for this device type
46catalogue numbers in this listing
7510(k) clearances naming this product code
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 | 2023-08-21 |
| Record revised | 2024-01-12 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UFIII 3811S | Ø3.8X11.5mm | In distribution |
| UFIII 4013UV3 | Ø4.0X13mm | In distribution |
| UFIII 5011UV3 | Ø5.0X11.5mm | In distribution |
| UFIII 4510UV3 | Ø4.5X10mm | In distribution |
| UFIII 4507S | Ø4.5X7mm | In distribution |
| UFIII 3807S | Ø3.8X8.5mm | In distribution |
| UFIII 5008UV3 | Ø5.0X8.5mm | In distribution |
| UFIII 4513UV3 | Ø4.5X13mm | In distribution |
| UFIII 5015S | Ø5.0X15mm | In distribution |
| UFIII 4007S | Ø4.0X7mm | In distribution |
| UFIII 4510S | Ø4.5X10mm | In distribution |
| UFIII 4011UV3 | Ø4.0X11.5mm | In distribution |
| UFIII 4507UV3 | Ø4.0X7mm | In distribution |
| UFIII 4508UV3 | Ø4.5X8.5mm | In distribution |
| UFIII 4007UV3 | Ø4.0X7mm | In distribution |
| UFIII 4010UV3 | Ø4.0X10mm | In distribution |
| UFIII 5008S | Ø5.0X8.5mm | In distribution |
| UFIII 5010UV3 | Ø5.0X10mm | In distribution |
| UFIII 4508S | Ø4.5X8.5mm | In distribution |
| UFIII 3810UV3 | Ø3.8X10mm | In distribution |
| UFIII 4013S | Ø4.0X13mm | In distribution |
| UFIII 3815S | Ø3.8X15mm | In distribution |
| UFIII 5011S | Ø5.0X11.5mm | In distribution |
| UFIII 4008S | Ø4.0X8.5mm | In distribution |
| UFIII 4011S | Ø4.0X11.5mm | In distribution |
| UFIII 3811UV3 | Ø3.8X11.5mm | In distribution |
| UFIII 4008UV3 | Ø4.0X8.5mm | In distribution |
| UFIII 3813S | Ø3.8X13mm | In distribution |
| UFIII 3808UV3 | Ø3.8X8mm | In distribution |
| UFIII 5013S | Ø5.0X13mm | In distribution |
| UFIII 3808S | Ø3.8X8.5mm | In distribution |
| UFIII 3810S | Ø3.8X10mm | In distribution |
| UFIII 4515S | Ø4.5X15mm | In distribution |
| UFIII 4010S | Ø4.0X10mm | In distribution |
| UFIII 5016S | Ø5.0X16mm | In distribution |
| UFIII 3813UV3 | Ø3.8X13mm | In distribution |
| UFIII 4513S | Ø4.5X13mm | In distribution |
| UFIII 4511S | Ø4.5X11.5mm | In distribution |
| UFIII 5007S | Ø5.0X7mm | In distribution |
| UFIII 5007UV3 | Ø5.0X7mm | In distribution |
| UFIII 5010S | Ø5.0X10mm | In distribution |
| UFIII 4015S | Ø4.0X15mm | In distribution |
| UFIII 4516S | Ø4.5X16mm | In distribution |
| UFIII 4016S | Ø4.0X16mm | In distribution |
| UFIII 4511UV3 | Ø4.5X11.5mm | In distribution |
| UFIII 5013UV3 | Ø5.0X13mm | In distribution |
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.