ESI
ESI Implant - Internal Hex - 6.0mmx11.5mm RBM Surface
7manufacturers in China registered for this device type
88catalogue 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 | Spiraltech Superior Dental Implants, Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Record published | 2018-03-12 |
| Record revised | 2025-03-03 (version 4) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESIC43010A | In distribution | |
| ESIC50015A | In distribution | |
| ESI60011A | In distribution | |
| ESIC50011A | In distribution | |
| ESIC60013R | In distribution | |
| ESI35010R | In distribution | |
| ESIC35008A | In distribution | |
| ESIC43010R | In distribution | |
| ESI50013R | In distribution | |
| ESI43010R | In distribution | |
| ESIC35013R | In distribution | |
| ESIC30013R | In distribution | |
| ESIC35015R | In distribution | |
| ESI43013R | In distribution | |
| ESI60015R | In distribution | |
| ESIC35011A | In distribution | |
| ESIC60010A | In distribution | |
| ESIC50008A | In distribution | |
| ESI60013A | In distribution | |
| ESIC43011R | In distribution | |
| ESI60008R | In distribution | |
| ESI35015R | In distribution | |
| ESIC43013R | In distribution | |
| ESIC30011A | In distribution | |
| ESI50013A | In distribution | |
| ESIC35015A | In distribution | |
| ESIC30015R | In distribution | |
| ESI35015A | In distribution | |
| ESIC43015R | In distribution | |
| ESI43008R | In distribution | |
| ESIC35010A | In distribution | |
| ESI35008A | In distribution | |
| ESIC30015A | In distribution | |
| ESI60010A | In distribution | |
| ESI43011A | In distribution | |
| ESI43010A | In distribution | |
| ESI35011A | In distribution | |
| ESIC60008R | In distribution | |
| ESIC50013R | In distribution | |
| ESIC35010R | In distribution | |
| ESIC43011A | In distribution | |
| ESI43015R | In distribution | |
| ESIC35008R | In distribution | |
| ESI60011R | In distribution | |
| ESIC60015A | In distribution | |
| ESIC60010R | In distribution | |
| ESIC43008R | In distribution | |
| ESI43011R | In distribution | |
| ESI60015A | In distribution | |
| ESI60008A | In distribution | |
| ESI35011R | In distribution | |
| ESIC60011A | In distribution | |
| ESI60013R | In distribution | |
| ESIC60011R | In distribution | |
| ESIC35013A | In distribution | |
| ESIC50015R | In distribution | |
| ESI50008A | In distribution | |
| ESI50011R | In distribution | |
| ESIC30011R | In distribution | |
| ESI50008R | In distribution | |
| ESIC30013A | In distribution | |
| ESI50010R | In distribution | |
| ESIC50008R | In distribution | |
| ESIC60015R | In distribution | |
| ESIC43015A | In distribution | |
| ESIC60008A | In distribution | |
| ESI43013A | In distribution | |
| ESIC50010A | In distribution | |
| ESI50015A | In distribution | |
| ESIC35011R | In distribution | |
| ESIC43013A | In distribution | |
| ESI43015A | In distribution | |
| ESIC43008A | In distribution | |
| ESI50010A | In distribution | |
| ESI60010R | In distribution | |
| ESI35008R | In distribution | |
| ESI50011A | In distribution | |
| ESIC35010A | In distribution | |
| ESI43008A | In distribution | |
| ESIC30010R | In distribution | |
| ESIC50013A | In distribution | |
| ESI35013R | In distribution | |
| ESI50015R | In distribution | |
| ESI35013A | In distribution | |
| ESIC50010R | In distribution | |
| ESIC50011R | In distribution | |
| ESI35010A | In distribution | |
| ESIC60013A | 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 |
|---|---|
| K170372 | 2017-06-30 |
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.