DenQ Sub SLA Fixture I
5.95x13.5, Bone level
7manufacturers in China registered for this device type
204catalogue numbers in this listing
1510(k) clearance
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 | Denq 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) | K240977 |
| Record published | 2026-03-05 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 1 to 30 °C |
| Distribution end date | 2025-01-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSSR35125S | In distribution | |
| DSSR45130 | In distribution | |
| DSSR35085S | In distribution | |
| DSSW60135S | In distribution | |
| DSSW70145 | In distribution | |
| DSSR40120S | In distribution | |
| DSSW60105S | In distribution | |
| DSSW70090S | In distribution | |
| DSSR45125S | In distribution | |
| DSSR45100 | In distribution | |
| DSSR40140 | In distribution | |
| DSSR35105S | In distribution | |
| DSSR50080 | In distribution | |
| DSSR40110S | In distribution | |
| DSSR45140S | In distribution | |
| DSSR50130 | In distribution | |
| DSSW60095 | In distribution | |
| DSSR50070 | In distribution | |
| DSSW70100S | In distribution | |
| DSSR50105S | In distribution | |
| DSSR35105 | In distribution | |
| DSSR45085S | In distribution | |
| DSSW60100 | In distribution | |
| DSSR35110 | In distribution | |
| DSSR35095S | In distribution | |
| DSSR35090 | In distribution | |
| DSSR50090 | In distribution | |
| DSSR35130S | In distribution | |
| DSSR40150 | In distribution | |
| DSSR45105 | In distribution | |
| DSSR40075 | In distribution | |
| DSSW70105 | In distribution | |
| DSSR40140S | In distribution | |
| DSSW70100 | In distribution | |
| DSSW70120S | In distribution | |
| DSSR50085S | In distribution | |
| DSSW60080S | In distribution | |
| DSSW60105 | In distribution | |
| DSSR45115S | In distribution | |
| DSSW60070S | In distribution | |
| DSSR35100 | In distribution | |
| DSSR40135S | In distribution | |
| DSSR35080S | In distribution | |
| DSSW60110S | In distribution | |
| DSSR40145 | In distribution | |
| DSSW60115S | In distribution | |
| DSSR40070 | In distribution | |
| DSSW60115 | In distribution | |
| DSSR50135S | In distribution | |
| DSSR45125 | In distribution | |
| DSSW60100S | In distribution | |
| DSSW70085 | In distribution | |
| DSSR40110 | In distribution | |
| DSSW70075 | In distribution | |
| DSSR50145 | In distribution | |
| DSSR50120 | In distribution | |
| DSSR40070S | In distribution | |
| DSSW60070 | In distribution | |
| DSSW70130S | In distribution | |
| DSSW60140 | In distribution | |
| DSSW60075S | In distribution | |
| DSSW70105S | In distribution | |
| DSSW70080S | In distribution | |
| DSSR50135 | In distribution | |
| DSSR50145S | In distribution | |
| DSSW70150 | In distribution | |
| DSSR35140S | In distribution | |
| DSSR50125S | In distribution | |
| DSSW60085S | In distribution | |
| DSSW70110 | In distribution | |
| DSSW70095 | In distribution | |
| DSSR50150S | In distribution | |
| DSSR45075S | In distribution | |
| DSSR50140S | In distribution | |
| DSSR40085S | In distribution | |
| DSSW70115 | In distribution | |
| DSSR45110S | In distribution | |
| DSSR45095S | In distribution | |
| DSSR40090S | In distribution | |
| DSSR40095S | In distribution | |
| DSSW60145 | In distribution | |
| DSSR35140 | In distribution | |
| DSSR35135S | In distribution | |
| DSSR45120 | In distribution | |
| DSSW60095S | In distribution | |
| DSSW60120S | In distribution | |
| DSSR35145 | In distribution | |
| DSSR45070S | In distribution | |
| DSSR35090S | In distribution | |
| DSSR40100 | In distribution | |
| DSSW60130 | In distribution | |
| DSSR50070S | In distribution | |
| DSSR40130S | In distribution | |
| DSSR45090S | In distribution | |
| DSSR35085 | In distribution | |
| DSSR40080S | In distribution | |
| DSSW70120 | In distribution | |
| DSSW70070 | In distribution | |
| DSSW60140S | In distribution | |
| DSSW70095S | In distribution | |
| DSSR50115S | In distribution | |
| DSSW70070S | In distribution | |
| DSSR50110S | In distribution | |
| DSSR35135 | In distribution | |
| DSSR45070 | In distribution | |
| DSSR45130S | In distribution | |
| DSSR40115 | In distribution | |
| DSSR40105S | In distribution | |
| DSSW70125 | In distribution | |
| DSSR45095 | In distribution | |
| DSSR35115 | In distribution | |
| DSSR35110S | In distribution | |
| DSSR50085 | In distribution | |
| DSSR45110 | In distribution | |
| DSSR45145S | In distribution | |
| DSSR40125S | In distribution | |
| DSSR40150S | In distribution | |
| DSSW70150S | In distribution | |
| DSSR50100S | In distribution | |
| DSSW70090 | In distribution | |
| DSSR35070 | In distribution | |
| DSSW60075 | In distribution | |
| DSSR45080 | In distribution | |
| DSSW60130S | In distribution | |
| DSSR40145S | In distribution | |
| DSSR50125 | In distribution | |
| DSSR50095S | In distribution | |
| DSSR50100 | In distribution | |
| DSSR45120S | In distribution | |
| DSSR50110 | In distribution | |
| DSSR35150S | In distribution | |
| DSSW70140 | In distribution | |
| DSSR40090 | In distribution | |
| DSSR40115S | In distribution | |
| DSSR35130 | In distribution | |
| DSSR50090S | In distribution | |
| DSSW70075S | In distribution | |
| DSSR40125 | In distribution | |
| DSSW60085 | In distribution | |
| DSSW60145S | In distribution | |
| DSSR40085 | In distribution | |
| DSSR45140 | In distribution | |
| DSSR40080 | In distribution | |
| DSSR50115 | In distribution | |
| DSSW60125S | In distribution | |
| DSSR45150 | In distribution | |
| DSSR45100S | In distribution | |
| DSSR35095 | In distribution | |
| DSSW60135 | In distribution | |
| DSSW60110 | In distribution | |
| DSSR50095 | In distribution | |
| DSSR45075 | In distribution | |
| DSSW60150 | In distribution | |
| DSSR40100S | In distribution | |
| DSSR35075S | In distribution | |
| DSSR50075S | In distribution | |
| DSSW70115S | In distribution | |
| DSSW60125 | In distribution | |
| DSSR45105S | In distribution | |
| DSSR35150 | In distribution | |
| DSSW70080 | In distribution | |
| DSSR50105 | In distribution | |
| DSSW70085S | In distribution | |
| DSSR45135 | In distribution | |
| DSSR45090 | In distribution | |
| DSSR35100S | In distribution | |
| DSSW70135 | In distribution | |
| DSSR50120S | In distribution | |
| DSSW70110S | In distribution | |
| DSSR40095 | In distribution | |
| DSSR35115S | In distribution | |
| DSSW70135S | In distribution | |
| DSSR50150 | In distribution | |
| DSSW60090 | In distribution | |
| DSSR45145 | In distribution | |
| DSSW60150S | In distribution | |
| DSSR50130S | In distribution | |
| DSSR45135S | In distribution | |
| DSSW60090S | In distribution | |
| DSSR50080S | In distribution | |
| DSSR35120 | In distribution | |
| DSSR35125 | In distribution | |
| DSSR45150S | In distribution | |
| DSSR45115 | In distribution | |
| DSSR45080S | In distribution | |
| DSSR40135 | In distribution | |
| DSSR35120S | In distribution | |
| DSSW70140S | In distribution | |
| DSSR40130 | In distribution | |
| DSSR50140 | In distribution | |
| DSSR40105 | In distribution | |
| DSSW70145S | In distribution | |
| DSSW60120 | In distribution | |
| DSSW70125S | In distribution | |
| DSSR50075 | In distribution | |
| DSSR40075S | In distribution | |
| DSSR35145S | In distribution | |
| DSSR35075 | In distribution | |
| DSSW70130 | In distribution | |
| DSSW60080 | In distribution | |
| DSSR40120 | In distribution | |
| DSSR35070S | In distribution | |
| DSSR45085 | In distribution | |
| DSSR35080 | 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 |
|---|---|
| K240977 | 2024-09-13 |
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.