Roott
Dental Implant, ROOTT R, D 4.2 mm, L 12 mm.
7manufacturers in China registered for this device type
51catalogue numbers in this listing
1510(k) clearance
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 | Trate LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K220022 |
| Record published | 2024-11-12 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Pack of 5 |
| Sizes | Height 1 to 6 mm; length 8 to 16 mm; width 3.5 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R4212 | Diameter 4.2 mm | In distribution | |
| R3816 | Length 16 mm | In distribution | |
| R3512 | Length 12 mm | In distribution | |
| M4 | Connection: screw-retained | 5 | In distribution |
| A4 | Height 4 mm | 5 | In distribution |
| R4810 | Diameter 4.8 mm | In distribution | |
| A4A25 | Height 4 mm | 5 | In distribution |
| R5510 | Diameter 5.5 mm | In distribution | |
| R3516 | Length 16 mm | In distribution | |
| R5508 | Diameter 5.5 mm | In distribution | |
| R4216 | Length 16 mm | In distribution | |
| MS1 | Connection: screw-retained | 5 | In distribution |
| A1A15 | Height 1 mm | 5 | In distribution |
| R3810 | Diameter 3.8 mm | In distribution | |
| GFN6 | Height 6 mm | 5 | In distribution |
| M3A15 | Connection: screw-retained | 5 | In distribution |
| R3514 | Length 14 mm | In distribution | |
| GF5 | Height 5 mm | 5 | In distribution |
| A4A15 | Height 4 mm | 5 | In distribution |
| R4208 | Length 8 mm | In distribution | |
| GFN2 | Height 2 mm | 5 | In distribution |
| R3814 | Diameter 3.8 mm | In distribution | |
| M2 | Connection: screw-retained | 5 | In distribution |
| A2A25 | Height 2 mm | 5 | In distribution |
| R5512 | Length 12 mm | In distribution | |
| R4808 | Diameter 4.8 mm | In distribution | |
| A3A15 | Height 3 mm | 5 | In distribution |
| A3A25 | Height 3 mm | 5 | In distribution |
| M2A15 | Connection: screw-retained | 5 | In distribution |
| MS2 | Connection: screw-retained | 5 | In distribution |
| A2 | Height 2 mm | 5 | In distribution |
| M3 | Connection: screw-retained | 5 | In distribution |
| R3808 | Length 8 mm | In distribution | |
| GF6 | Height 6 mm | 5 | In distribution |
| M1A15 | Connection: screw-retained | 5 | In distribution |
| GFN4 | Height 4 mm | 5 | In distribution |
| R3812 | Diameter 3.8 mm | In distribution | |
| A1A25 | Height 1 mm | 5 | In distribution |
| R4214 | Diameter 4.2 mm | In distribution | |
| R3510 | Length 10 mm | In distribution | |
| GF1 | Height 1 mm | 5 | In distribution |
| A3 | Height 3 mm | 5 | In distribution |
| A1N | Connection: cement-retained | 5 | In distribution |
| GF2 | Height 2 mm | 5 | In distribution |
| R4812 | Diameter 4.8 mm | In distribution | |
| A1 | Height 1 mm | 5 | In distribution |
| M1 | Connection: screw-retained | 5 | In distribution |
| R3814 | Length 14 mm | In distribution | |
| A2A15 | Height 2 mm | 5 | In distribution |
| R4210 | Diameter 4.2 mm | In distribution | |
| R3508 | Diameter 3.5 mm | 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 |
|---|---|
| K220022 | 2022-04-04 |
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.