Tsiii BA Fixture
TSIII BA is a permanent dental implant fixture for anchoring restorations in the upper or lower jaw. Its tapered, self-tapping body has a single-thread design and an internal hexagonal…
TSIII BA is a permanent dental implant fixture for anchoring restorations in the upper or lower jaw. Its tapered, self-tapping body has a single-thread design and an internal hexagonal connection for the restorative assembly.
The fixture is commercially pure Grade 4 titanium. Its BA surface is sandblasted and acid etched, then coated with calcium phosphate and hydrophilic materials including glucose and sodium chloride. These treatments apply to the fixture’s surface.
Restoration Context
The system supports single or multiple restorations, including cement-retained, screw-retained and overdenture arrangements, and is intended for delayed loading. Fixtures are supplied sterile and come in different diameters and lengths. A fixture provides the bone-anchoring component; the abutment and prosthetic restoration complete the assembly.
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 | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K163088 |
| Record published | 2017-06-23 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS3S5010B | In distribution | |
| TS3S4008B | In distribution | |
| TS3S4013B | In distribution | |
| BTS3S4510B | In distribution | |
| TS3M3508B | In distribution | |
| BTS3S4011B | In distribution | |
| BTS3M3510B | In distribution | |
| TS3S4511B | In distribution | |
| TS3M3510B | In distribution | |
| TS3M3511B | In distribution | |
| BTS3S5013B | In distribution | |
| TS3S4007B | In distribution | |
| BTS3S4508B | In distribution | |
| TS3M3513B | In distribution | |
| BTS3S4008B | In distribution | |
| BTS3S5007B | In distribution | |
| BTS3S4511B | In distribution | |
| BTS3S5011B | In distribution | |
| TS3S5007B | In distribution | |
| BTS3M3511B | In distribution | |
| TS3S4513B | In distribution | |
| BTS3M3508B | In distribution | |
| TS3S4510B | In distribution | |
| TS3S4010B | In distribution | |
| BTS3S4513B | In distribution | |
| TS3S4011B | In distribution | |
| TS3S4508B | In distribution | |
| BTS3S4013B | In distribution | |
| BTS3M3513B | In distribution | |
| BTS3S4507B | In distribution | |
| TS3S5008B | In distribution | |
| BTS3S4007B | In distribution | |
| TS3S5013B | In distribution | |
| BTS3S5008B | In distribution | |
| TS3S5011B | In distribution | |
| BTS3S5010B | In distribution | |
| TS3S4507B | In distribution | |
| BTS3S4010B | 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 |
|---|---|
| K222778 | 2023-09-23 |
| K163557 | 2017-05-15 |
| K163088 | 2017-04-21 |
| K161103 | 2017-02-02 |
| K161604 | 2016-10-17 |
| K121585 | 2013-01-07 |
| K121995 | 2012-11-29 |
| K122171 | 2012-11-16 |
| K120847 | 2012-08-10 |
| K091208 | 2010-03-03 |
| K091678 | 2010-02-18 |
| K083633 | 2009-05-01 |
| K083067 | 2009-02-02 |
| K082213 | 2008-10-14 |
| K080594 | 2008-09-03 |
| K080744 | 2008-07-17 |
| K081078 | 2008-07-15 |
| K073465 | 2008-04-07 |
| K080387 | 2008-03-07 |
| K073247 | 2008-03-07 |
| K072959 | 2008-02-04 |
| K072871 | 2008-01-10 |
| K072896 | 2007-11-06 |
| K063861 | 2007-09-21 |
| K062030 | 2006-11-02 |
| K062051 | 2006-11-01 |
| K062156 | 2006-10-20 |
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.