Inno SLA Mini Plus Implant System
INNO SLA Mini Plus is a one-piece dental implant combining an implant body and abutment section. It is made from commercially pure titanium with a sandblasted and acid-etched surface.…
INNO SLA Mini Plus is a one-piece dental implant combining an implant body and abutment section. It is made from commercially pure titanium with a sandblasted and acid-etched surface.
Cement and ball-head types serve different temporary restorative roles. The cement type supports provisional replacement of selected incisors during healing, while the ball type supports an overdenture.
Temporary Loading Configurations
Ball-type use is limited to 180 days. Both types have an immediate-loading option only when primary stability and occlusal loading are appropriate. The integrated abutment differs from a two-piece system in which a separate abutment is later attached to the implant body.
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 | Cowellmedi 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) | K241127 |
| Record published | 2025-10-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
|---|---|---|
| AMC3414S | In distribution | |
| AMB2212S | In distribution | |
| AMC3212S | In distribution | |
| AMC2210S | In distribution | |
| AMC2410S | In distribution | |
| AMC2414S | In distribution | |
| AMB3214S | In distribution | |
| AMB3412S | In distribution | |
| AMC3410S | In distribution | |
| AMC2214S | In distribution | |
| AMB2210S | In distribution | |
| AMC2212S | In distribution | |
| AMC3214S | In distribution | |
| AMB3210S | In distribution | |
| AMB3414S | In distribution | |
| AMB2410S | In distribution | |
| AMB2412S | In distribution | |
| AMB2414S | In distribution | |
| AMB3410S | In distribution | |
| AMC2412S | In distribution | |
| AMC3412S | In distribution | |
| AMC3210S | In distribution | |
| AMB2214S | In distribution | |
| AMB3212S | 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 |
|---|---|
| K241127 | 2024-12-27 |
| K231395 | 2023-10-18 |
| K132242 | 2013-12-06 |
| K100850 | 2010-12-20 |
| K090054 | 2009-07-29 |
| K090049 | 2009-04-20 |
| K071148 | 2008-02-06 |
| K050635 | 2005-07-28 |
| K041655 | 2004-09-08 |
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.