Titan Implants, Inc.
3.75mm Diameter, 4.1mm Platform Straight External Hex Implant Length: 13.0mm Sandblast
7manufacturers in China registered for this device type
156catalogue numbers in this listing
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 | Titan Implant Inc |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K042971 |
| Record published | 2017-01-06 |
| Record revised | 2024-10-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Distribution end date | 2024-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T-37SE15R | In distribution | |
| IS-48/6TG14R1 | In distribution | |
| T-3SE15R | In distribution | |
| T-37SE11R | In distribution | |
| IS-48/6TG14S2 | In distribution | |
| T-5/6SE11S | In distribution | |
| T-5SE13S | In distribution | |
| T-5TE15R | In distribution | |
| T-37SE13S | In distribution | |
| IS-48/4TG12S2 | In distribution | |
| BC-45S8S | In distribution | |
| IS-3/4TG8R1 | In distribution | |
| T-34SE13R | In distribution | |
| T-6SE85S | In distribution | |
| T-6SE11R | In distribution | |
| IS-41/4TG12S1 | In distribution | |
| T-6SE10S | In distribution | |
| T-5/6SE13S | In distribution | |
| T-6SE13R | In distribution | |
| IS-3/4TG10S1 | In distribution | |
| T-37SE85R | In distribution | |
| T-3SE13S | In distribution | |
| T-6TE15S | In distribution | |
| T-3SE15S | In distribution | |
| T-6TE10R | In distribution | |
| T-4TE10S | In distribution | |
| IS-41/4TG14R1 | In distribution | |
| T-6SE85R | In distribution | |
| T-6SE13S | In distribution | |
| T-5SE85R | In distribution | |
| T-5TE13S | In distribution | |
| T-4SE11R | In distribution | |
| T-4SE13S | In distribution | |
| T-34SE85S | In distribution | |
| T-4/5SE11S | In distribution | |
| T-4SE15S | In distribution | |
| T-3SE85S | In distribution | |
| T-5SE13R | In distribution | |
| IS-41/4TG10S1 | In distribution | |
| IS-3/4TG12R1 | In distribution | |
| T-4SE85S | In distribution | |
| T-34SE10R | In distribution | |
| T-4SE10R | In distribution | |
| T-5TE10R | In distribution | |
| IS-48/4TG8R1 | In distribution | |
| T-37SE15S | In distribution | |
| BC-45S11S | In distribution | |
| IS-41/4TG12S2 | In distribution | |
| T-5SE10S | In distribution | |
| IS-48/4TG14R1 | In distribution | |
| T-34SE11S | In distribution | |
| T-37SE10R | In distribution | |
| IS-48/4TG8S2 | In distribution | |
| T-4TE11R | In distribution | |
| IS-48/6TG10S2 | In distribution | |
| T-4SE85R | In distribution | |
| T-4SE13R | In distribution | |
| T-4TE15S | In distribution | |
| T-37SE13R | In distribution | |
| IS-48/4TG10S2 | In distribution | |
| T-4TE13R | In distribution | |
| T-4TE11S | In distribution | |
| T-5/6SE85S | In distribution | |
| T-4SE11S | In distribution | |
| IS-3/4TG14R1 | In distribution | |
| T-6TE11S | In distribution | |
| IS-48/4TG10R1 | In distribution | |
| T-6SE11S | In distribution | |
| T-5SE7R | In distribution | |
| T-5TE85S | In distribution | |
| IS-41/4TG8R1 | In distribution | |
| T-6SE15S | In distribution | |
| T-6TE85R | In distribution | |
| IS-48/6TG12S2 | In distribution | |
| T-4SE10S | In distribution | |
| IS-41/4TG12R1 | In distribution | |
| IS-41/4TG10S2 | In distribution | |
| T-5TE15S | In distribution | |
| T-5SE85S | In distribution | |
| T-37SE11S | In distribution | |
| IS-48/4TG10S1 | In distribution | |
| T-6SE15R | In distribution | |
| IS-3/4TG14S1 | In distribution | |
| IS-3/4TG10R1 | In distribution | |
| T-6TE13R | In distribution | |
| IS-41/4TG14S2 | In distribution | |
| T-4/5SE13S | In distribution | |
| T-3SE85R | In distribution | |
| T-6TE10S | In distribution | |
| T-34SE11R | In distribution | |
| T-6TE15R | In distribution | |
| T-4/5SE10S | In distribution | |
| T-4/5SE85S | In distribution | |
| T-5TE10S | In distribution | |
| T-5TE11S | In distribution | |
| T-5SE10R | In distribution | |
| T-3SE11S | In distribution | |
| T-5SE11S | In distribution | |
| T-5TE13R | In distribution | |
| T-5/6SE10S | In distribution | |
| T-4TE15R | In distribution | |
| T-6TE11R | In distribution | |
| T-4TE85S | In distribution | |
| T-34SE13S | In distribution | |
| IS-3/4TG8S1 | In distribution | |
| T-4TE10R | In distribution | |
| T-5SE7S | In distribution | |
| T-4SE15R | In distribution | |
| T-5TE85R | In distribution | |
| T-5SE11R | In distribution | |
| T-4TE13S | In distribution | |
| T-37SE85S | In distribution | |
| T-37SE10S | In distribution | |
| T-5/6SE15S | In distribution | |
| T-4/5SE15S | In distribution | |
| IS-48/4TG14S2 | In distribution | |
| T-4TE85R | In distribution | |
| T-6TE85S | In distribution | |
| T-6TE13S | In distribution | |
| T-34SE10S | In distribution | |
| T-5TE11R | In distribution | |
| IS-3/4TG12S1 | In distribution | |
| T-3SE10R | Withdrawn | |
| P-6TI13S | Withdrawn | |
| P-47TI16S | Withdrawn | |
| P-3SI13S | Withdrawn | |
| T-3SE10S | Withdrawn | |
| P-47TI8S | Withdrawn | |
| P-47TI13S | Withdrawn | |
| P-3SI16S | Withdrawn | |
| P-37TI13S | Withdrawn | |
| P-47TI11S | Withdrawn | |
| BC-5S11S | Withdrawn | |
| P-47TI10S | Withdrawn | |
| BC-4S11S | Withdrawn | |
| BC-4S8S | Withdrawn | |
| T-3SE11R | Withdrawn | |
| P-3SI11S | Withdrawn | |
| P-6TI16S | Withdrawn | |
| P-6TI11S | Withdrawn | |
| P-3SI10S | Withdrawn | |
| P-37TI11S | Withdrawn | |
| BC-3S8S | Withdrawn | |
| P-37TI16S | Withdrawn | |
| BC-6S8S | Withdrawn | |
| BC-3S11S | Withdrawn | |
| P-37SI13S | Withdrawn | |
| P-3SI8S | Withdrawn | |
| BC-5S8S | Withdrawn | |
| P-37SI11S | Withdrawn | |
| P-4TI10S | Withdrawn | |
| P-4TI11S | Withdrawn | |
| P-6TI8S | Withdrawn | |
| P-6TI10S | Withdrawn | |
| P-4TI8S | Withdrawn | |
| P-37TI10S | 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
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.