Tryon
Implant Tryon CM Cylindrical Ø4.0X15.0MM
7manufacturers in China registered for this device type
117catalogue 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 | SIN Sistema DE Implante Nacional S.A |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K193096 |
| Record published | 2022-04-26 |
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 |
|---|---|---|
| SCOT 513 | In distribution | |
| ST 4015 | In distribution | |
| SC 5015 | In distribution | |
| ST 5010 | In distribution | |
| SCPL 5015 | In distribution | |
| SC 4010 | In distribution | |
| SCOT 415 | In distribution | |
| SA 3210 | In distribution | |
| SCPL 3585 | In distribution | |
| SCPL 3511 | In distribution | |
| SC 3515 | In distribution | |
| SA 407 | In distribution | |
| SA 485 | In distribution | |
| SA 310 | In distribution | |
| ST 3585 | In distribution | |
| SA 585 | In distribution | |
| SC 5013 | In distribution | |
| SL 515 | In distribution | |
| SA 3285 | In distribution | |
| SCPL 5013 | In distribution | |
| SCPL 3515 | In distribution | |
| SL 511 | In distribution | |
| SA 415ST | In distribution | |
| SA 3215 | In distribution | |
| SC 3585 | In distribution | |
| SA 413 | In distribution | |
| ST 5013 | In distribution | |
| ST 5015 | In distribution | |
| ST 3715 | In distribution | |
| SL 411 | In distribution | |
| ST 3507 | In distribution | |
| SA 513 | In distribution | |
| SA 313 | In distribution | |
| SA 411 | In distribution | |
| SA 315 | In distribution | |
| SCPL 5011 | In distribution | |
| ST 3713 | In distribution | |
| SCOT 413 | In distribution | |
| SA 315ST | In distribution | |
| SL 415 | In distribution | |
| ST 4085 | In distribution | |
| SC 5011 | In distribution | |
| SCOT 411 | In distribution | |
| SA 410ST | In distribution | |
| SA 311ST | In distribution | |
| ST 3513 | In distribution | |
| SL 310 | In distribution | |
| SL 485 | In distribution | |
| ST 4010 | In distribution | |
| SA 3585ST | In distribution | |
| SA 515 | In distribution | |
| SL 313 | In distribution | |
| SC 3510 | In distribution | |
| SA 511 | In distribution | |
| SC 4015 | In distribution | |
| SCOT 485 | In distribution | |
| SC 4011 | In distribution | |
| ST 3510 | In distribution | |
| ST 3515 | In distribution | |
| SA 3211 | In distribution | |
| SA 413ST | In distribution | |
| ST 4007 | In distribution | |
| SA 311 | In distribution | |
| SL 315 | In distribution | |
| ST 3511 | In distribution | |
| SC 5085 | In distribution | |
| SA 510 | In distribution | |
| SA 307 | In distribution | |
| SA 3213 | In distribution | |
| ST 3711 | In distribution | |
| SA 415 | In distribution | |
| SCPL 4013 | In distribution | |
| ST 3710 | In distribution | |
| SA 385 | In distribution | |
| SCPL 3510 | In distribution | |
| SCPL 4085 | In distribution | |
| SA 3513ST | In distribution | |
| SCPL 5010 | In distribution | |
| SA 507 | In distribution | |
| SL 413 | In distribution | |
| SC 3511 | In distribution | |
| SCOT 410 | In distribution | |
| SL 513 | In distribution | |
| SA 385ST | In distribution | |
| SA 411ST | In distribution | |
| SL 510 | In distribution | |
| ST 5011 | In distribution | |
| ST 5085 | In distribution | |
| ST 4013 | In distribution | |
| ST 4011 | In distribution | |
| SCPL 3513 | In distribution | |
| ST 3785 | In distribution | |
| SC 4013 | In distribution | |
| SA 3510ST | In distribution | |
| ST 3707 | In distribution | |
| SA 485ST | In distribution | |
| SC 3513 | In distribution | |
| SA 310ST | In distribution | |
| ST 5007 | In distribution | |
| SL 410 | In distribution | |
| SL 311 | In distribution | |
| SL 385 | In distribution | |
| SCPL 5085 | In distribution | |
| SA 3515ST | In distribution | |
| SCPL 4015 | In distribution | |
| SL 585 | In distribution | |
| SCPL 4010 | In distribution | |
| SCPL 4011 | In distribution | |
| SCOT 510 | In distribution | |
| SCOT 585 | In distribution | |
| SA 313ST | In distribution | |
| SCOT 511 | In distribution | |
| SC 4085 | In distribution | |
| SA 3511ST | In distribution | |
| SA 410 | In distribution | |
| SC 5010 | In distribution | |
| SCOT 515 | 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
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.