Locator Overdenture Implant System
LOCATOR Overdenture Implant Implant, 2.4mmD x 10mmL, 4mm Cuff
7manufacturers in China registered for this device type
119catalogue numbers in this listing
8510(k) clearances naming this product code
3recalls on this code
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 | Zest Anchors, 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, Repacker / relabeller, Manufacturer |
| Record published | 2022-07-07 |
| Record revised | 2026-03-02 (version 3) |
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 |
| Sizes | Length 2.5 to 14 mm |
| Distribution end date | 2026-05-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07510-02 | Length 10 mm | In distribution |
| 07511-03 | Length 12 mm | In distribution |
| 07508 | Length 14 mm | In distribution |
| 07452 | Length 14 mm | In distribution |
| 07512-03 | Length 14 mm | In distribution |
| 07383 | Length 12 mm | In distribution |
| 07513-05 | Length 8 mm | In distribution |
| 07511-04 | Length 12 mm | In distribution |
| 07456 | Length 12 mm | In distribution |
| 07501-03 | Length 8 mm | In distribution |
| 07510-04 | Length 10 mm | In distribution |
| 07462 | Length 14 mm | In distribution |
| 07514 | Length 10 mm | In distribution |
| 07507-02 | Length 12 mm | In distribution |
| 07503 | Length 12 mm | In distribution |
| 07512-02 | Length 14 mm | In distribution |
| 07466 | Length 12 mm | In distribution |
| 07502-05 | Length 10 mm | In distribution |
| 07504-05 | Length 14 mm | In distribution |
| 07513-04 | Length 8 mm | In distribution |
| 07445 | Length 14 mm | In distribution |
| 07467 | Length 14 mm | In distribution |
| 07509-03 | Length 8 mm | In distribution |
| 07501-02 | Length 8 mm | In distribution |
| 07442 | Length 14 mm | In distribution |
| 07513-02 | Length 8 mm | In distribution |
| 07510 | Length 10 mm | In distribution |
| 07443 | Length 10 mm | In distribution |
| 07515-04 | Length 12 mm | In distribution |
| 07508-02 | Length 14 mm | In distribution |
| 07444 | Length 12 mm | In distribution |
| 07451 | Length 12 mm | In distribution |
| 07512-04 | Length 14 mm | In distribution |
| 07381 | Length 10 mm | In distribution |
| 07461 | Length 12 mm | In distribution |
| 07441 | Length 12 mm | In distribution |
| 07506-02 | Length 10 mm | In distribution |
| 07515-02 | Length 12 mm | In distribution |
| 07509-02 | Length 8 mm | In distribution |
| 07516-04 | Length 14 mm | In distribution |
| 07507-05 | Length 12 mm | In distribution |
| 07509-04 | Length 8 mm | In distribution |
| 07457 | Length 14 mm | In distribution |
| 07504-03 | Length 14 mm | In distribution |
| 07382 | Length 12 mm | In distribution |
| 07506 | Length 10 mm | In distribution |
| 07440 | Length 10 mm | In distribution |
| 07455 | Length 10 mm | In distribution |
| 07512 | Length 14 mm | In distribution |
| 07505 | Length 8 mm | In distribution |
| 07508-03 | Length 14 mm | In distribution |
| 07503-05 | Length 12 mm | In distribution |
| 07515-05 | Length 12 mm | In distribution |
| 07320 | Length 6 mm | In distribution |
| 07513-03 | Length 8 mm | In distribution |
| 07437 | Length 14 mm | In distribution |
| 07508-04 | Length 14 mm | In distribution |
| 07388 | Length 14 mm | In distribution |
| 07514-05 | Length 10 mm | In distribution |
| 07513 | Length 8 mm | In distribution |
| 07506-04 | Length 10 mm | In distribution |
| 07511-05 | Length 12 mm | In distribution |
| 07504-04 | Length 14 mm | In distribution |
| 07502-03 | Length 10 mm | In distribution |
| 07387 | Length 12 mm | In distribution |
| 07386 | Length 10 mm | In distribution |
| 07501-05 | Length 8 mm | In distribution |
| 07435 | Length 10 mm | In distribution |
| 07505-04 | Length 8 mm | In distribution |
| 07510-03 | Length 10 mm | In distribution |
| 07434 | Length 14 mm | In distribution |
| 07465 | Length 10 mm | In distribution |
| 07501 | Length 10 mm | In distribution |
| 07506-03 | Length 10 mm | In distribution |
| 07460 | Length 10 mm | In distribution |
| 07515-03 | Length 12 mm | In distribution |
| 07436 | Length 12 mm | In distribution |
| 07504 | Length 14 mm | In distribution |
| 07505-05 | Length 8 mm | In distribution |
| 07319 | Length 5 mm | In distribution |
| 07501-04 | Length 8 mm | In distribution |
| 07506-05 | Length 10 mm | In distribution |
| 07516-05 | Length 14 mm | In distribution |
| 07511 | Length 12 mm | In distribution |
| 07514-04 | Length 10 mm | In distribution |
| 07514-03 | Length 10 mm | In distribution |
| 07515 | Length 12 mm | In distribution |
| 07516 | Length 14 mm | In distribution |
| 07507-04 | Length 12 mm | In distribution |
| 07509-05 | Length 8 mm | In distribution |
| 07505-03 | Length 8 mm | In distribution |
| 07504-02 | Length 14 mm | In distribution |
| 07508-05 | Length 14 mm | In distribution |
| 07516-03 | Length 14 mm | In distribution |
| 07503-03 | Length 12 mm | In distribution |
| 07318 | Length 3 mm | In distribution |
| 07432 | Length 5 mm | In distribution |
| 07502 | Length 10 mm | In distribution |
| 07450 | Length 10 mm | In distribution |
| 07516-02 | Length 14 mm | In distribution |
| 07433 | Length 10 mm | In distribution |
| 07505-02 | Length 8 mm | In distribution |
| 07511-02 | Length 12 mm | In distribution |
| 07510-05 | Length 10 mm | In distribution |
| 07503-04 | Length 12 mm | In distribution |
| 07507 | Length 12 mm | In distribution |
| 07503-02 | Length 12 mm | In distribution |
| 07502-04 | Length 10 mm | In distribution |
| 07512-05 | Length 14 mm | In distribution |
| 07507-03 | Length 12 mm | In distribution |
| 07502-02 | Length 10 mm | In distribution |
| 07509 | Length 8 mm | In distribution |
| 07514-02 | Length 10 mm | In distribution |
| 07472 | Length 2.5 mm | Withdrawn |
| 07477 | Length 4 mm | Withdrawn |
| 07470 | Length 2.5 mm | Withdrawn |
| 07475 | Length 4 mm | Withdrawn |
| 07471 | Length 2.5 mm | Withdrawn |
| 07476 | Length 4 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133327 | 2014-06-25 |
| K120198 | 2012-06-06 |
| K033699 | 2004-04-22 |
| K994257 | 2000-03-17 |
| K925849 | 1994-11-18 |
| K934668 | 1994-06-22 |
| K840244 | 1984-05-01 |
| K801524 | 1980-07-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Zest Anchors, LLC | UDI-DI | 2019-11-22 | Class II | Process control | The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. | 154 kits |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-01-16 | Class II | Unknown/Undetermined by firm | Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently not | 3,130 | 2014-05-15 |
| 2008-04-09 | Not classified | Nonconforming Material/Component | The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TS | 996 units | 2008-12-02 |
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.