Leone SPA
Abutment O-Ring Overdenture Impl 3,3 GH7
7manufacturers in China registered for this device type
404catalogue 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 | Leone SPA, Italy |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K050586 |
| Record published | 2019-04-25 |
| Record revised | 2019-11-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 126-3315-07 | In distribution | |
| 123-3307-00 | In distribution | |
| 126-2221-07 | In distribution | |
| 126-3301-25 | In distribution | |
| 110-4108-02 | In distribution | |
| 126-3325-07 | In distribution | |
| 126-3301-01 | In distribution | |
| 124-4103-04 | In distribution | |
| 131-4105-55 | In distribution | |
| 121-4104-00 | In distribution | |
| 121-3308-00 | In distribution | |
| 126-4107-01 | In distribution | |
| 129-3300-03 | In distribution | |
| 110-4814-03 | In distribution | |
| 110-3312-03 | In distribution | |
| 111-2716-13 | In distribution | |
| 126-4100-00 | In distribution | |
| 121-4806-15 | In distribution | |
| 123-4105-00 | In distribution | |
| 126-3003-07 | In distribution | |
| 110-3814-02 | In distribution | |
| 126-0010-48 | In distribution | |
| 126-3323-07 | In distribution | |
| 131-3305-45 | In distribution | |
| 126-4115-25 | In distribution | |
| 126-4121-25 | In distribution | |
| 126-2221-15 | In distribution | |
| 129-3301-01 | In distribution | |
| 123-4805-00 | In distribution | |
| 126-0204-30 | In distribution | |
| 123-4807-15 | In distribution | |
| 126-3305-35 | In distribution | |
| 111-2710-15 | In distribution | |
| 129-3302-02 | In distribution | |
| 126-4123-15 | In distribution | |
| 130-4800-48 | In distribution | |
| 129-4100-02 | In distribution | |
| 129-4501-00 | In distribution | |
| 129-4100-01 | In distribution | |
| 110-4512-03 | In distribution | |
| 125-4803-60 | In distribution | |
| 126-4105-07 | In distribution | |
| 129-3300-00 | In distribution | |
| 110-2914-03 | In distribution | |
| 123-3307-15 | In distribution | |
| 129-4501-02 | In distribution | |
| 125-4803-48 | In distribution | |
| 123-3300-01 | In distribution | |
| 126-3325-15 | In distribution | |
| 126-3001-25 | In distribution | |
| 111-2714-15 | In distribution | |
| 123-4949-30 | In distribution | |
| 126-4803-15 | In distribution | |
| 126-4123-35 | In distribution | |
| 130-4800-41 | In distribution | |
| 129-3300-01 | In distribution | |
| 126-2223-15 | In distribution | |
| 110-3808-02 | In distribution | |
| 126-3311-15 | In distribution | |
| 131-4107-55 | In distribution | |
| 124-4803-01 | In distribution | |
| 120-3310-45 | In distribution | |
| 126-3005-01 | In distribution | |
| 129-5502-02 | In distribution | |
| 126-3315-15 | In distribution | |
| 126-3005-07 | In distribution | |
| 126-4121-07 | In distribution | |
| 123-3300-03 | In distribution | |
| 126-2225-25 | In distribution | |
| 129-4502-00 | In distribution | |
| 123-3305-00 | In distribution | |
| 126-0010-33 | In distribution | |
| 110-4808-33 | In distribution | |
| 110-2912-03 | In distribution | |
| 126-4123-07 | In distribution | |
| 130-4100-41 | In distribution | |
| 126-3311-07 | In distribution | |
| 129-4801-02 | In distribution | |
| 126-4113-15 | In distribution | |
| 126-3303-25 | In distribution | |
| 126-4113-07 | In distribution | |
| 126-3003-01 | In distribution | |
| 123-4115-03 | In distribution | |
| 126-4123-25 | In distribution | |
| 126-4121-15 | In distribution | |
| 126-3001-07 | In distribution | |
| 123-4107-15 | In distribution | |
| 131-4103-55 | In distribution | |
| 126-2221-01 | In distribution | |
| 123-4107-00 | In distribution | |
| 133-4801-48 | In distribution | |
| 121-4106-15 | In distribution | |
| 126-3325-25 | In distribution | |
| 126-3023-15 | In distribution | |
| 126-4803-25 | In distribution | |
| 126-2225-07 | In distribution | |
| 126-3307-01 | In distribution | |
| 110-3812-02 | In distribution | |
| 131-4807-48 | In distribution | |
| 126-3025-25 | In distribution | |
| 126-3313-01 | In distribution | |
| 126-3311-25 | In distribution | |
| 126-2223-07 | In distribution | |
| 132-4103-41 | In distribution | |
| 126-3325-01 | In distribution | |
| 110-4514-03 | In distribution | |
| 126-4803-01 | In distribution | |
| 126-4103-35 | In distribution | |
| 126-4111-07 | In distribution | |
| 126-0410-30 | In distribution | |
| 110-4108-03 | In distribution | |
| 110-4810-03 | In distribution | |
| 126-4111-01 | In distribution | |
| 129-4502-02 | In distribution | |
| 126-2225-01 | In distribution | |
| 110-4510-02 | In distribution | |
| 126-2230-00 | In distribution | |
| 110-3812-03 | In distribution | |
| 129-3301-00 | In distribution | |
| 126-4807-01 | In distribution | |
| 121-3315-00 | In distribution | |
| 126-4123-01 | In distribution | |
| 126-2205-01 | In distribution | |
| 110-4810-33 | In distribution | |
| 126-2203-25 | In distribution | |
| 129-4502-01 | In distribution | |
| 126-3315-35 | In distribution | |
| 110-3310-02 | In distribution | |
| 125-3303-45 | In distribution | |
| 123-4115-01 | In distribution | |
| 123-3301-15 | In distribution | |
| 126-4105-15 | In distribution | |
| 126-4801-01 | In distribution | |
| 110-4508-03 | In distribution | |
| 126-3303-35 | In distribution | |
| 126-3313-25 | In distribution | |
| 126-0810-22 | In distribution | |
| 126-4121-01 | In distribution | |
| 126-0010-41 | In distribution | |
| 126-3025-01 | In distribution | |
| 126-4125-35 | In distribution | |
| 129-4100-03 | In distribution | |
| 126-4111-15 | In distribution | |
| 110-4110-03 | In distribution | |
| 127-3301-10 | In distribution | |
| 126-3323-35 | In distribution | |
| 131-4807-60 | In distribution | |
| 123-4100-05 | In distribution | |
| 110-3308-02 | In distribution | |
| 123-4805-15 | In distribution | |
| 129-3302-00 | In distribution | |
| 131-3307-45 | In distribution | |
| 129-5501-00 | In distribution | |
| 123-4100-01 | In distribution | |
| 110-2912-02 | In distribution | |
| 126-3305-25 | In distribution | |
| 126-3305-01 | In distribution | |
| 123-3315-01 | In distribution | |
| 126-0810-30 | In distribution | |
| 110-4514-02 | In distribution | |
| 129-3303-01 | In distribution | |
| 123-3301-00 | In distribution | |
| 129-5502-00 | In distribution | |
| 126-3005-25 | In distribution | |
| 110-4810-30 | In distribution | |
| 129-4101-02 | In distribution | |
| 110-4814-02 | In distribution | |
| 110-4808-02 | In distribution | |
| 126-3300-00 | In distribution | |
| 131-3303-33 | In distribution | |
| 128-4100-00 | In distribution | |
| 126-4113-25 | In distribution | |
| 126-3303-01 | In distribution | |
| 126-4103-07 | In distribution | |
| 126-2225-15 | In distribution | |
| 124-4803-02 | In distribution | |
| 110-4112-02 | In distribution | |
| 123-4801-00 | In distribution | |
| 120-4810-60 | In distribution | |
| 123-4336-30 | In distribution | |
| 125-3303-33 | In distribution | |
| 123-4801-15 | In distribution | |
| 126-2205-15 | In distribution | |
| 126-3303-07 | In distribution | |
| 129-4802-00 | In distribution | |
| 126-4805-01 | In distribution | |
| 121-4804-00 | In distribution | |
| 125-4103-41 | In distribution | |
| 110-4112-03 | In distribution | |
| 126-4101-25 | In distribution | |
| 126-3300-38 | In distribution | |
| 126-3021-15 | In distribution | |
| 110-2914-02 | In distribution | |
| 111-2712-13 | In distribution | |
| 126-0101-00 | In distribution | |
| 124-4103-01 | In distribution | |
| 110-4812-33 | In distribution | |
| 126-0003-41 | In distribution | |
| 120-4810-37 | In distribution | |
| 120-4110-55 | In distribution | |
| 110-4512-02 | In distribution | |
| 129-4501-01 | In distribution | |
| 126-2201-07 | In distribution | |
| 123-4105-15 | In distribution | |
| 121-4106-00 | In distribution | |
| 110-4812-02 | In distribution | |
| 126-0003-48 | In distribution | |
| 123-4803-00 | In distribution | |
| 123-3315-05 | In distribution | |
| 126-3323-01 | In distribution | |
| 129-4803-01 | In distribution | |
| 110-4808-30 | In distribution | |
| 120-4810-48 | In distribution | |
| 110-5065-02 | In distribution | |
| 120-3310-33 | In distribution | |
| 124-4103-03 | In distribution | |
| 123-4807-00 | In distribution | |
| 123-3303-15 | In distribution | |
| 131-4805-60 | In distribution | |
| 126-4125-07 | In distribution | |
| 129-4102-02 | In distribution | |
| 129-4102-00 | In distribution | |
| 126-3001-15 | In distribution | |
| 128-3300-00 | In distribution | |
| 111-2716-15 | In distribution | |
| 129-4803-02 | In distribution | |
| 110-2910-02 | In distribution | |
| 126-3325-35 | In distribution | |
| 126-2205-07 | In distribution | |
| 110-3314-03 | In distribution | |
| 121-3306-00 | In distribution | |
| 129-4103-02 | In distribution | |
| 127-4801-10 | In distribution | |
| 123-4100-03 | In distribution | |
| 121-4105-51 | In distribution | |
| 126-2221-25 | In distribution | |
| 123-4803-15 | In distribution | |
| 110-4508-02 | In distribution | |
| 131-4107-41 | In distribution | |
| 129-4101-01 | In distribution | |
| 130-3300-33 | In distribution | |
| 126-2015-00 | In distribution | |
| 126-0204-22 | In distribution | |
| 129-3303-00 | In distribution | |
| 126-3317-01 | In distribution | |
| 126-0101-06 | In distribution | |
| 126-3323-25 | In distribution | |
| 126-2223-01 | In distribution | |
| 126-0210-30 | In distribution | |
| 121-3305-51 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
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.