Highness Implant System
Highness Implant System provides titanium dental fixtures and compatible abutments for crowns, bridges and overdentures in partially or fully edentulous jaws. Fixtures are surgically placed…
Highness Implant System provides titanium dental fixtures and compatible abutments for crowns, bridges and overdentures in partially or fully edentulous jaws. Fixtures are surgically placed in the upper or lower jaw to support prosthetic teeth. The fixture surface is sandblasted and acid-etched.
Fixtures are supplied sterile after gamma irradiation. Abutments use titanium alloy and are supplied nonsterile for user sterilization. The HS-I and HS-VII implant bodies share compatible abutments, with separate designs for single-unit or multiple-unit restorations and healing components.
Listed Item
Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prosthesis. Made of titanium grade 4 with SLA surface treatment.
Loading Conditions
Implants smaller than 5.5 mm in diameter are intended for immediate loading only when good primary stability and appropriate occlusal loading are achieved. Larger implants are intended for the molar region with delayed loading. Multi-unit abutments are restricted to multiple-unit restorations and permit up to 25 degrees when connecting a cylinder.
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 | Highness Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K240383 |
| Record published | 2025-12-10 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HS-I4010 | In distribution | |
| HS-VII4015 | In distribution | |
| HS-I7011 | In distribution | |
| HS-I4513 | In distribution | |
| HS-I4007 | In distribution | |
| HS-VII6015 | In distribution | |
| HS-VII5015 | In distribution | |
| HS-I5015 | In distribution | |
| HS-VII7007 | In distribution | |
| HS-VII4013 | In distribution | |
| HS-VII6007 | In distribution | |
| HS-VII7013 | In distribution | |
| HS-VII4011 | In distribution | |
| HS-I5507 | In distribution | |
| HS-I7007 | In distribution | |
| HS-VII4010 | In distribution | |
| HS-VII5011 | In distribution | |
| HS-I5515 | In distribution | |
| HS-I4511 | In distribution | |
| HS-VII7010 | In distribution | |
| HS-I6010 | In distribution | |
| HS-VII5008 | In distribution | |
| HS-VII4507 | In distribution | |
| HS-I5011 | In distribution | |
| HS-I5008 | In distribution | |
| HS-VII6008 | In distribution | |
| HS-I4015 | In distribution | |
| HS-VII6010 | In distribution | |
| HS-VII7008 | In distribution | |
| HS-VII5511 | In distribution | |
| HS-VII4510 | In distribution | |
| HS-I4507 | In distribution | |
| HS-I5510 | In distribution | |
| HS-I7008 | In distribution | |
| HS-I5013 | In distribution | |
| HS-VII5507 | In distribution | |
| HS-I7010 | In distribution | |
| HS-VII5013 | In distribution | |
| HS-VII7011 | In distribution | |
| HS-I4508 | In distribution | |
| HS-VII5010 | In distribution | |
| HS-VII6013 | In distribution | |
| HS-I6007 | In distribution | |
| HS-VII4515 | In distribution | |
| HS-I7013 | In distribution | |
| HS-I4515 | In distribution | |
| HS-I6015 | In distribution | |
| HS-VII4508 | In distribution | |
| HS-I6008 | In distribution | |
| HS-I6011 | In distribution | |
| HS-I5511 | In distribution | |
| HS-VII4008 | In distribution | |
| HS-VII4007 | In distribution | |
| HS-VII5508 | In distribution | |
| HS-VII4513 | In distribution | |
| HS-VII4511 | In distribution | |
| HS-I6013 | In distribution | |
| HS-I4510 | In distribution | |
| HS-VII5513 | In distribution | |
| HS-I5007 | In distribution | |
| HS-VII5510 | In distribution | |
| HS-I5508 | In distribution | |
| HS-VII5515 | In distribution | |
| HS-I4008 | In distribution | |
| HS-I4013 | In distribution | |
| HS-VII5007 | In distribution | |
| HS-I4011 | In distribution | |
| HS-VII6011 | In distribution | |
| HS-I5513 | In distribution | |
| HS-I5010 | 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 |
|---|---|
| K240383 | 2024-10-31 |
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.