Reflect Implant System
Reflect Aspire 4.5/5.0 Healing Abutment 5.5D x 2H
7manufacturers in China registered for this device type
108catalogue numbers in this listing
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 | Integrated Dental Systems, LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| 510(k) | K180924 |
| Record published | 2020-05-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RS4015C | In distribution | |
| RR5011C | In distribution | |
| RCICC41S | In distribution | |
| RSHA452 | In distribution | |
| RA5085C | In distribution | |
| RSHA464 | In distribution | |
| RSICC50S | In distribution | |
| RSHA466 | In distribution | |
| RT4708C | In distribution | |
| RR3510C | In distribution | |
| RCHA4504C | In distribution | |
| RA5015C | In distribution | |
| RT4713C | In distribution | |
| RCHA5564 | In distribution | |
| RCICC50S | In distribution | |
| RR5008C | In distribution | |
| RCHA3384C | In distribution | |
| RR5016C | In distribution | |
| RC5085C | In distribution | |
| RR5010C | In distribution | |
| RS5011C | In distribution | |
| RC4113C | In distribution | |
| RT4113C | In distribution | |
| RSHA346 | In distribution | |
| RCHA4412C | In distribution | |
| RCHA3382C | In distribution | |
| RSHA456 | In distribution | |
| RT4710C | In distribution | |
| RR4313C | In distribution | |
| RC3413C | In distribution | |
| RR3508C | In distribution | |
| RT3711C | In distribution | |
| RA4313C | In distribution | |
| RS3515C | In distribution | |
| RSICC40S | In distribution | |
| RSHA344 | In distribution | |
| RC3485C | In distribution | |
| RS4013C | In distribution | |
| RA3515C | In distribution | |
| RSHA342 | In distribution | |
| RT4711C | In distribution | |
| RS4008C | In distribution | |
| RT4716C | In distribution | |
| RT4110C | In distribution | |
| RA5013C | In distribution | |
| RCHA4503C | In distribution | |
| RCHA3383C | In distribution | |
| RSHA364 | In distribution | |
| RT3716C | In distribution | |
| RS3508C | In distribution | |
| RA4311C | In distribution | |
| RS5009C | In distribution | |
| RA3513C | In distribution | |
| RR5013C | In distribution | |
| RS5015C | In distribution | |
| RS3509C | In distribution | |
| RA5011C | In distribution | |
| RCHA4503C | In distribution | |
| RC4185C | In distribution | |
| RT3713C | In distribution | |
| RT3710C | In distribution | |
| RSHA354 | In distribution | |
| RC5010C | In distribution | |
| RA4310C | In distribution | |
| RCICC34S | In distribution | |
| RA4315C | In distribution | |
| RS4009C | In distribution | |
| RCHA4502C | In distribution | |
| RR3511C | In distribution | |
| RS5013c | In distribution | |
| RC3410C | In distribution | |
| RC4110C | In distribution | |
| RR4308C | In distribution | |
| RCHA4416C | In distribution | |
| RR4316C | In distribution | |
| RCHA4413C | In distribution | |
| RR3513C | In distribution | |
| RA5010C | In distribution | |
| RCCS50 | In distribution | |
| RS4011C | In distribution | |
| RC5013C | In distribution | |
| RCHA3386C | In distribution | |
| RA3510C | In distribution | |
| RC4111C | In distribution | |
| RA3511C | In distribution | |
| RT4111C | In distribution | |
| RR3516C | In distribution | |
| RC3415C | In distribution | |
| RC4115C | In distribution | |
| RC3411C | In distribution | |
| RSHA462 | In distribution | |
| RC5015C | In distribution | |
| RR4311C | In distribution | |
| RT4108C | In distribution | |
| RR4310C | In distribution | |
| RSHA366 | In distribution | |
| RT4116C | In distribution | |
| RSHA352 | In distribution | |
| RSHA454 | In distribution | |
| RSHA356 | In distribution | |
| RCHA4504 | In distribution | |
| RT3708C | In distribution | |
| RCICO50S | In distribution | |
| RCHA4414C | In distribution | |
| RC5011C | In distribution | |
| RCHA4604 | In distribution | |
| RS3511C | In distribution | |
| RA4385C | 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
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.