AoN Implants
CYROTH IMPLANT D.4.00 - L.11.5 NanoTiOx w.Carrier EH
7manufacturers in China registered for this device type
140catalogue 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 | Faico Medical, LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Record published | 2020-08-04 |
| Record revised | 2024-09-18 (version 5) |
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, serial number |
| Distribution end date | 2023-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AIF50100N2000 | Withdrawn | |
| AIF37130N200C | Withdrawn | |
| ACY37080NP00I | Withdrawn | |
| ACY45115NP00I | Withdrawn | |
| ACY37115N200C | Withdrawn | |
| ACY37150NPCEE | Withdrawn | |
| AIF50150N200C | Withdrawn | |
| ACY40150NPCEE | Withdrawn | |
| AIF33150N2000 | Withdrawn | |
| ACY60080NP00I | Withdrawn | |
| ACY60115NP00I | Withdrawn | |
| ACY37170NP00I | Withdrawn | |
| ACY60070NP00I | Withdrawn | |
| ACY40070N200C | Withdrawn | |
| ACY60115N200C | Withdrawn | |
| AKA40080NPCEE | Withdrawn | |
| ACY33100NPCEE | Withdrawn | |
| ACY50115NP00I | Withdrawn | |
| ACY40115NP00I | Withdrawn | |
| ACY50150N200C | Withdrawn | |
| AIF33150N200C | Withdrawn | |
| ACY37100N200C | Withdrawn | |
| ACY33150NP00I | Withdrawn | |
| ACY45170NP00I | Withdrawn | |
| ACY33170NP00I | Withdrawn | |
| ACY45150N200C | Withdrawn | |
| ACY45100N200C | Withdrawn | |
| ACY50080N200C | Withdrawn | |
| ACY50100NP00I | Withdrawn | |
| ACY40115NPCEE | Withdrawn | |
| ACY40100NPCEE | Withdrawn | |
| ACY37130NPCEE | Withdrawn | |
| ACY40080N200C | Withdrawn | |
| AIF33115N200C | Withdrawn | |
| ACY50130NPCEE | Withdrawn | |
| AKA40115NPCEE | Withdrawn | |
| AIF37115N200C | Withdrawn | |
| AIF42100N200C | Withdrawn | |
| AKA40100NPCEE | Withdrawn | |
| ACY40100NP00I | Withdrawn | |
| ACY50150NPCEE | Withdrawn | |
| ACY45100NP00I | Withdrawn | |
| AIF33115N2000 | Withdrawn | |
| AIF50150N2000 | Withdrawn | |
| ACY50080NPCEE | Withdrawn | |
| ACY33100N200C | Withdrawn | |
| ACY37130N200C | Withdrawn | |
| ACY45070NP00I | Withdrawn | |
| ACY50100N200C | Withdrawn | |
| AKA40150NPCEE | Withdrawn | |
| ACY40070NP00I | Withdrawn | |
| ACY50130NP00I | Withdrawn | |
| ACY40150N200C | Withdrawn | |
| AKA33100NPCEE | Withdrawn | |
| AKA33115NPCEE | Withdrawn | |
| ACY33130N200C | Withdrawn | |
| AIF42130N2000 | Withdrawn | |
| ACY33150NPCEE | Withdrawn | |
| ACY50080NP00I | Withdrawn | |
| ACY45070N200C | Withdrawn | |
| AKA50130NPCEE | Withdrawn | |
| ACY40150NP00I | Withdrawn | |
| ACY33130NP00I | Withdrawn | |
| AKA40130NPCEE | Withdrawn | |
| AIF33130N200C | Withdrawn | |
| AKA33130NPCEE | Withdrawn | |
| AIF37130N2000 | Withdrawn | |
| AKA50150NPCEE | Withdrawn | |
| ACY37100NPCEE | Withdrawn | |
| ACY37115NP00I | Withdrawn | |
| ACY40080NPCEE | Withdrawn | |
| AIF42080N200C | Withdrawn | |
| AKA50115NPCEE | Withdrawn | |
| ACY33115NP00I | Withdrawn | |
| ACY40130NP00I | Withdrawn | |
| AIF42080N2000 | Withdrawn | |
| AIF37150N2000 | Withdrawn | |
| AIF37115N2000 | Withdrawn | |
| AIF42150N2000 | Withdrawn | |
| ACY40080NP00I | Withdrawn | |
| ACY40130N200C | Withdrawn | |
| AIF50080N2000 | Withdrawn | |
| ACY37080NPCEE | Withdrawn | |
| ACY50170NP00I | Withdrawn | |
| AKA33150NPCEE | Withdrawn | |
| ACY40100N200C | Withdrawn | |
| ACY50150NP00I | Withdrawn | |
| AIF50130N200C | Withdrawn | |
| AIF50080N200C | Withdrawn | |
| AIF33100N2000 | Withdrawn | |
| ACY60070N200C | Withdrawn | |
| AIF42115N2000 | Withdrawn | |
| ACY50100NPCEE | Withdrawn | |
| ACY37115NPCEE | Withdrawn | |
| ACY37080N200C | Withdrawn | |
| AIF42115N200C | Withdrawn | |
| ACY40170NP00I | Withdrawn | |
| ACY37100NP00I | Withdrawn | |
| AIF50100N200C | Withdrawn | |
| AIF37080N2000 | Withdrawn | |
| ACY37130NP00I | Withdrawn | |
| ACY33100NP00I | Withdrawn | |
| AIF37080N200C | Withdrawn | |
| ACY45080NP00I | Withdrawn | |
| ACY45115N200C | Withdrawn | |
| AIF37100N200C | Withdrawn | |
| AKA50100NPCEE | Withdrawn | |
| ACY40115N200C | Withdrawn | |
| ACY33115N200C | Withdrawn | |
| AIF37100N2000 | Withdrawn | |
| ACY37150NP00I | Withdrawn | |
| ACY60100N200C | Withdrawn | |
| ACY50070N200C | Withdrawn | |
| ACY45150NP00I | Withdrawn | |
| AIF42130N200C | Withdrawn | |
| ACY33150N200C | Withdrawn | |
| AIF33100N200C | Withdrawn | |
| AIF50130N2000 | Withdrawn | |
| ACY37150N200C | Withdrawn | |
| ACY60100NP00I | Withdrawn | |
| ACY50070NP00I | Withdrawn | |
| ACY60130N200C | Withdrawn | |
| AKA50080NPCEE | Withdrawn | |
| ACY60130NP00I | Withdrawn | |
| ACY50115N200C | Withdrawn | |
| ACY40130NPCEE | Withdrawn | |
| ACY45130N200C | Withdrawn | |
| ACY33115NPCEE | Withdrawn | |
| ACY60080N200C | Withdrawn | |
| ACY33130NPCEE | Withdrawn | |
| AIF42100N2000 | Withdrawn | |
| ACY45130NP00I | Withdrawn | |
| ACY45080N200C | Withdrawn | |
| AIF50115N2000 | Withdrawn | |
| ACY50115NPCEE | Withdrawn | |
| AIF37150N200C | Withdrawn | |
| ACY50130N200C | Withdrawn | |
| AIF33130N2000 | Withdrawn | |
| AIF50115N200C | Withdrawn | |
| AIF42150N200C | 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 |
|---|---|
| K192015 | 2020-04-03 |
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.