Inno SLA Submerged Hybrid Ti-Base System-Hybrid a Ti-Base
Hybrid A Ti-Base is the titanium-alloy base of a two-piece dental abutment. A patient-designed zirconia superstructure is joined to the prefabricated base, and the two parts form the final…
Hybrid A Ti-Base is the titanium-alloy base of a two-piece dental abutment. A patient-designed zirconia superstructure is joined to the prefabricated base, and the two parts form the final abutment.
A screw secures the base to an INNO SLA Submerged implant fixture. The completed assembly supports single- or multiple-unit cement-retained restorations in the upper or lower jaw.
Superstructure and Manufacturing
The described configuration uses InCoris Zi zirconia and RelyX Unicem 2 Automix cement. Digitally designed zirconia superstructures are manufactured at a Cowellmedi-validated milling center. Hybrid A is one of the system’s S, L and A Ti-Base forms; the base is Ti-6Al-4V ELI alloy.
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 | Cowellmedi Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer |
| 510(k) | K231411 |
| Record published | 2024-05-24 |
| Record revised | 2025-10-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2SLH404A | In distribution | |
| 2SLN515 | In distribution | |
| 2SLN524 | In distribution | |
| 2SLH504 | In distribution | |
| 2SLH634 | In distribution | |
| 2SLN525 | In distribution | |
| 2SLH435 | In distribution | |
| 2SLN415 | In distribution | |
| 2SLN434A | In distribution | |
| 2SLH524 | In distribution | |
| 2SLN504 | In distribution | |
| 2SLH525 | In distribution | |
| 2SLN424A | In distribution | |
| 2SLN535 | In distribution | |
| 2SLH425 | In distribution | |
| 2SLH424 | In distribution | |
| 2SLN435 | In distribution | |
| 2SLH404 | In distribution | |
| 2SLN634 | In distribution | |
| 2SLN624 | In distribution | |
| 2SLH604 | In distribution | |
| 2SLH434A | In distribution | |
| 2SLN434 | In distribution | |
| 2SLH415 | In distribution | |
| 2SLN615 | In distribution | |
| 2SLN625 | In distribution | |
| 2SLN404 | In distribution | |
| 2SLN404A | In distribution | |
| 2SLH625 | In distribution | |
| 2SLH534 | In distribution | |
| 2SLN635 | In distribution | |
| 2SLH424A | In distribution | |
| 2SLH535 | In distribution | |
| 2SLH635 | In distribution | |
| 2SLN604 | In distribution | |
| 2SLN425 | In distribution | |
| 2SLH615 | In distribution | |
| 2SLN424 | In distribution | |
| 2SLN534 | In distribution | |
| 2SLH515 | In distribution | |
| 2SLH624 | In distribution | |
| 2SLH434 | 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 |
|---|---|
| K242287 | 2025-09-16 |
| K231411 | 2023-12-20 |
| K232546 | 2023-11-21 |
| K201323 | 2022-01-25 |
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.