Legacy™3 Implant
4.7mmD x 11.5mmL, 4.5mmD Platform
7manufacturers in China registered for this device type
68catalogue numbers in this listing
6510(k) clearances naming this product code
19recalls 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 | Implant Direct Sybron Manufacturing LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K090234 |
| Record published | 2015-09-14 |
| Record revised | 2024-12-19 (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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 864716 | 4.7mmD x 16mmL | In distribution |
| 853216 | 3.2mmD x 16mmL | In distribution |
| 853210 | 3.2mmD x 10mmL | In distribution |
| 863210 | 3.2mmD x 10mmL | In distribution |
| 863216 | 3.2mmD x 16mmL | In distribution |
| 854716 | 4.7mmD x 16mmL | In distribution |
| 863213 | 3.2mmD x 13mmL | In distribution |
| 854713 | 4.7mmD x 13mmL | In distribution |
| 865713 | 5.7mmD x 13mmL | In distribution |
| 854210 | 4.2mmD x 10mmL | In distribution |
| 865208 | 5.2mmD x 8mmL | In distribution |
| 865710 | 5.7mmD x 10mmL | In distribution |
| 864210 | 4.2mmD x 10mmL | In distribution |
| 867010 | 7.0mmD x 10mmL | In distribution |
| 864711 | 4.7mmD x 11.5mmL | In distribution |
| 854711 | 4.7mmD x 11.5mmL | In distribution |
| 867011 | 7.0mmD x 11.5mmL | In distribution |
| 855711 | 5.7mmD x 11.5mmL | In distribution |
| 857013 | 7.0mmD x 13mmL | In distribution |
| 854708 | 4.7mmD x 8mmL | In distribution |
| 863208 | 3.2mmD x 8mmL | In distribution |
| 863708 | 3.7mmD x 8mmL | In distribution |
| 853213 | 3.2mmD x 13mmL | In distribution |
| 853211 | 3.2mmD x 11.5mmL | In distribution |
| 864710 | 4.7mmD x 10mmL | In distribution |
| 853716 | 3.7mmD x 16mmL | In distribution |
| 864208 | 4.2mmD x 8mmL | In distribution |
| 865213 | 5.2mmD x 13mmL | In distribution |
| 867008 | 7.0mmD x 8mmL | In distribution |
| 855208 | 5.2mmD x 8mmL | In distribution |
| 864713 | 4.7mmD x 13mmL | In distribution |
| 863711 | 3.7mmD x 11.5mmL | In distribution |
| 853710 | 3.7mmD x 10mmL | In distribution |
| 864211 | 4.2mmD x 11.5mmL | In distribution |
| 855708 | 5.7mmD x 8mmL | In distribution |
| 863713 | 3.7mmD x 13mmL | In distribution |
| 857010 | 7.0mmD x 10mmL | In distribution |
| 863211 | 3.2mmD x 11.5mmL | In distribution |
| 865708 | 5.7mmD x 8mmL | In distribution |
| 853711 | 3.7mmD x 11.5mmL | In distribution |
| 865211 | 5.2mmD x 11.5mmL | In distribution |
| 853708 | 3.7mmD x 8mmL | In distribution |
| 864216 | 4.2mmD x 16mmL | In distribution |
| 863716 | 3.7mmD x 16mmL | In distribution |
| 855710 | 5.7mmD x 10mmL | In distribution |
| 853208 | 3.2mmD x 8mmL | In distribution |
| 855216 | 5.2mmD x 16mmL | In distribution |
| 855210 | 5.2mmD x 10mmL | In distribution |
| 865216 | 5.2mmD x 16mmL | In distribution |
| 864213 | 4.2mmD x 13mmL | In distribution |
| 857011 | 7.0mmD x 11.5mmL | In distribution |
| 855213 | 5.2mmD x 13mmL | In distribution |
| 865716 | 5.7mmD x 16mmL | In distribution |
| 854216 | 4.2mmD x 16mmL | In distribution |
| 855211 | 5.2mmD x 11.5mmL | In distribution |
| 853713 | 3.7mmD x 13mmL | In distribution |
| 854211 | 4.2mmD x 11.5mmL | In distribution |
| 863710 | 3.7mmD x 10mmL | In distribution |
| 855713 | 5.7mmD x 13mmL | In distribution |
| 865210 | 5.2mmD x 10mmL | In distribution |
| 855716 | 5.7mmD x 16mmL | In distribution |
| 857008 | 7.0mmD x 8mmL | In distribution |
| 854213 | 4.2mmD x 13mmL | In distribution |
| 854710 | 4.7mmD x 10mmL | In distribution |
| 854208 | 4.2mmD x 8mmL | In distribution |
| 864708 | 4.7mmD x 8mmL | In distribution |
| 867013 | 7.0mmD x 13mmL | In distribution |
| 865711 | 5.7mmD x 11.5mmL | 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 |
|---|---|
| K222211 | 2023-02-02 |
| K201553 | 2021-01-22 |
| K192221 | 2020-06-25 |
| K143011 | 2015-07-16 |
| K130572 | 2013-12-24 |
| K131097 | 2013-08-22 |
Recalls Naming This Product
12 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2021-09-23 | Class II | Packaging change control | Packaged dental implant contains a different size then the size declared on the labeling. | 61 implants | |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2021-09-23 | Class II | Packaging change control | Packaged dental implant contains a different size then the size declared on the labeling. | 83 implants | |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2019-10-11 | Class II | Mixed-up of materials/components | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to | 78 implants | 2024-04-12 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2019-10-07 | Class II | Packaging process control | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. | 72 | 2021-04-28 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2019-08-09 | Class II | Packaging | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. | 23 implants | 2021-04-27 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2018-08-08 | Class II | Employee error | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. | 22 vials | 2019-10-07 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2018-01-19 | Class II | Process control | The extender that is packaged with the SwishTapered” and SwishPlus” Implant may have been packaged in the incorrect position (upside down in the plastic retainer). | 1,117 units total | 2023-07-26 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2017-10-10 | Class II | Process design | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not | 75 units | 2018-09-27 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2016-12-12 | Class II | Packaging process control | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly | 17 | 2017-05-22 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2016-11-28 | Class II | Labeling mix-ups | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. | 14 | 2017-02-16 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2016-11-15 | Class II | Labeling mix-ups | The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. | 18 units | 2018-06-04 |
| Implant Direct Sybron Manufacturing LLC | 510(k) number | 2016-03-04 | Class II | Nonconforming Material/Component | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level. | 2033 | 2016-05-17 |
Recalls
7 of these are 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 |
|---|---|---|---|---|---|
| 2018-10-26 | Class II | Packaging | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. | 53 implants | |
| 2018-08-07 | Class II | Employee error | The incorrect device was packaged in the vial. | 158 devices | |
| 2018-05-18 | Class II | Process control | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant | 60 units | 2020-07-13 |
| 2018-03-14 | Class II | Labeling mix-ups | The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. | 298 implants | 2018-06-04 |
| 2017-05-02 | Class II | Nonconforming Material/Component | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. | 151 units | 2018-01-08 |
| 2017-03-03 | Class II | Process control | The main vial label lists the incorrect part number, but the cap label is correct. | 124 units | 2018-08-06 |
| 2016-07-05 | Class II | Process control | Issue with design specification; oversized condition. | 205 | 2017-02-16 |
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.