MOR®-A Implant
MOR-A Implant is a one-piece titanium alloy dental implant with a tapered prosthetic post for supporting crowns or bridges. The 3.0 mm implant body has a blasted and etched bone-contacting…
MOR-A Implant is a one-piece titanium alloy dental implant with a tapered prosthetic post for supporting crowns or bridges. The 3.0 mm implant body has a blasted and etched bone-contacting surface and is offered in 10, 13, 15 and 18 mm lengths.
The implant rehabilitates partially or fully edentulous upper or lower jaws. It is intended for straight abutment positioning without an angle correction, with single- or multiple-unit restorative options.
Listed Item
3.0 x 15mm, Ti. The MOR® is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V → ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with three body diameters, 2.1 mm, 2.4 mm, and 3.0mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR® implant body is designed with an O-ball denture connection or with a tapering post connection (MOR-A) which may also be used for crown and bridge replacement.
Loading and Supply
Delayed loading is intended, while immediate loading is indicated when primary stability is good and the occlusal load is appropriate. Implants are supplied sterile after gamma irradiation. The tapered post distinguishes MOR-A from the O-ball denture attachment version.
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 | Sterngold Dental LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K171728 |
| Record published | 2023-10-05 |
| Record revised | 2025-05-08 (version 2) |
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 |
|---|---|---|
| 901496 | 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 |
|---|---|
| K171728 | 2017-09-28 |
| K153173 | 2016-02-05 |
| K151928 | 2015-11-06 |
| K150968 | 2015-07-24 |
| K142667 | 2015-01-07 |
| K111798 | 2012-06-01 |
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.