Custom Legacy Titanium Abutment
Custom Legacy Titanium Abutments support crowns or bridges on compatible dental implants in the upper or lower jaw. They are patient specific final abutments with an engaging hexagonal…
Custom Legacy Titanium Abutments support crowns or bridges on compatible dental implants in the upper or lower jaw. They are patient specific final abutments with an engaging hexagonal connection and a fixation screw that secures the abutment to the implant platform.
The one piece abutment is made from Ti-6Al-4V ELI titanium alloy. Implant Direct’s Custom Direct laboratory mills it to individual specifications using a digital design workflow, with Legacy platform diameters of 3.0, 3.5, 4.5 and 5.7 mm.
Customization Limits
The final design permits a maximum angle of 30 degrees, a minimum wall thickness of 0.4 mm and a minimum post height of 4 mm. Abutments are supplied nonsterile for sterilization by the end user and are intended for single use.
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Implant Direct Sybron Manufacturing LLC, United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K192218 |
| Record published | 2015-09-23 |
| Record revised | 2020-08-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8045-31-XX | Order # XXXXXXXXXX Case # XXXXXXXX-XX | In distribution |
| 8035-31-XX | Order # XXXXXXXXXX Case # XXXXXXXX-XX | In distribution |
| 8530-31-XX | Order # XXXXXXXXXX Case # XXXXXXXX-XX | In distribution |
| 8057-31-XX | Order # XXXXXXXXXX Case # XXXXXXXX-XX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223535 | 2023-06-20 |
| K192218 | 2020-05-08 |
| K191458 | 2019-10-10 |
| K181359 | 2018-08-15 |
| K162633 | 2017-07-24 |
| K153509 | 2016-08-26 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-05-02 | Class II | No Marketing Application | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. | 29 | |
| 2019-01-09 | Class II | Process control | Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, howe | 11 units | 2021-04-27 |
| 2018-01-23 | Class II | Process control | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. | 55 units | 2018-08-09 |
| 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 |
| 2017-07-21 | Class II | Employee error | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. | 50 units | 2021-04-01 |
| 2015-10-28 | Class II | Unknown/Undetermined by firm | Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. | 478 | 2016-04-08 |
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.