UF(II) Narrow Implant System
286 catalogue numbers from UNSCA 40507H, listed by DIO Corporation, South Korea, under Abutment, Implant, Dental, Endosseous. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
286catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K161987 |
| Record published | 2018-08-23 |
| Record revised | 2022-02-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2022-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNSCA 40507H | In distribution | |
| UNSCA 45504H | In distribution | |
| UNSCA 40405H | In distribution | |
| UNSMUA 483020N | In distribution | |
| UNSKA 4802 | In distribution | |
| UNSAS 1407H | In distribution | |
| UNSHA 4560 | In distribution | |
| UNSHA 4024 | In distribution | |
| UNSCA 45107N | In distribution | |
| UNSAA 402015N | In distribution | |
| UNSCA 40405N | In distribution | |
| UNSHA 4558 | In distribution | |
| UNSCA 40305N | In distribution | |
| UNSCS 2710 | In distribution | |
| UNSCA 40307N | In distribution | |
| UNSCA 40105N | In distribution | |
| UNSCA 40705H | In distribution | |
| UNSCA 45105N | In distribution | |
| UNSCA 40705N | In distribution | |
| UNSAA 402015AH | In distribution | |
| UNSCA 45707H | In distribution | |
| UNSKA 4803 | In distribution | |
| UNSHA 4535 | In distribution | |
| UNSCS 2730S | In distribution | |
| UNSBA 3520 | In distribution | |
| UNSCA 40607H | In distribution | |
| UNSMUA 485020H | In distribution | |
| UNSCA 45307N | In distribution | |
| UNSHA 4020 | In distribution | |
| UNSCA 40105H | In distribution | |
| UNSCA 45505N | In distribution | |
| UNSCA 45704N | In distribution | |
| UNSHA 4047 | In distribution | |
| UNSCA 40707H | In distribution | |
| UNSHA 4035 | In distribution | |
| UNSCA 45204H | In distribution | |
| UNSHA 4520 | In distribution | |
| UNSTA 4010H | In distribution | |
| UNSCA 40207H | In distribution | |
| UNSCA 45205N | In distribution | |
| UNSAA 404015BH | In distribution | |
| UNSCA 40207N | In distribution | |
| UNSCS 2710S | In distribution | |
| UNSHA 4524 | In distribution | |
| UNSCA 45507H | In distribution | |
| UNSCA 40507N | In distribution | |
| UNSCA 45404H | In distribution | |
| UNSCA 45407N | In distribution | |
| UNSCS 2700S | In distribution | |
| UNSCA 45407H | In distribution | |
| UNSCS 2700 | In distribution | |
| UNSCS 2720S | In distribution | |
| UNSCA 40505N | In distribution | |
| UNSAA 404015AH | In distribution | |
| UNSBA 3570 | In distribution | |
| UNSBA 3530 | In distribution | |
| UNSTA 4030H | In distribution | |
| UNSCA 45707N | In distribution | |
| UNSCA 40407H | In distribution | |
| UNSCA 45504N | In distribution | |
| UNSCA 45205H | In distribution | |
| UNSCA 45204N | In distribution | |
| UNSMUA 483020H | In distribution | |
| UNSMUA 484020N | In distribution | |
| UNSCA 40107N | In distribution | |
| UNSCA 40505H | In distribution | |
| UNSCA 45607N | In distribution | |
| UNSCA 45207N | In distribution | |
| UNSCA 45705H | In distribution | |
| UNSCA 45605N | In distribution | |
| UNSCA 45605H | In distribution | |
| UNSBA 3540 | In distribution | |
| UNSCA 45405H | In distribution | |
| UNSCA 40605N | In distribution | |
| UNSCA 45604H | In distribution | |
| UNSCA 40605H | In distribution | |
| UNSCA 45404N | In distribution | |
| UNSBA 3560 | In distribution | |
| UNSCA 45104H | In distribution | |
| UNSCA 45305N | In distribution | |
| UNSCA 45505H | In distribution | |
| UNSCA 45704H | In distribution | |
| UNSCA 45105H | In distribution | |
| UNSTA 4030N | In distribution | |
| UNSCA 45207H | In distribution | |
| UNSCA 40307H | In distribution | |
| UNSCA 40305H | In distribution | |
| UNSHA 4547 | In distribution | |
| UNSHA 4058 | In distribution | |
| UNSCA 40205H | In distribution | |
| UNSKA 4801 | In distribution | |
| UNSCA 45304H | In distribution | |
| UNSBA 3550 | In distribution | |
| UNSCA 40707N | In distribution | |
| UNSHA 4060 | In distribution | |
| UNSMUA 484020H | In distribution | |
| UNSCA 45304N | In distribution | |
| UNSCA 40407N | In distribution | |
| UNSAA 402015BH | In distribution | |
| UNSTA 4010N | In distribution | |
| UNSCA 45604N | In distribution | |
| UNSCA 45607H | In distribution | |
| UNSCA 45104N | In distribution | |
| UNSCS 2720 | In distribution | |
| UNSCS 2730 | In distribution | |
| UNSCA 40107H | In distribution | |
| UNSCA 45307H | In distribution | |
| UNSCA 45305H | In distribution | |
| UNSCA 45507N | In distribution | |
| UNSCA 45405N | In distribution | |
| UNSAA 404015N | In distribution | |
| UNSCA 45705N | In distribution | |
| UNSCA 40205N | In distribution | |
| UNSCA 45305N | Withdrawn | |
| UNSCA 45707N | Withdrawn | |
| UNSCA 45405N | Withdrawn | |
| UNSAA 402015N | Withdrawn | |
| UNSTA 4010N | Withdrawn | |
| UNSHA 4520 | Withdrawn | |
| UNSMUA 482520N | Withdrawn | |
| UNSAA 402015AH | Withdrawn | |
| UNSSA 45505 | Withdrawn | |
| UNSCA 45407H | Withdrawn | |
| UNSSA 40504 | Withdrawn | |
| UNSCA 45607H | Withdrawn | |
| UNSKA 4802 | Withdrawn | |
| UNSSA 45705 | Withdrawn | |
| UNSCA 40504N | Withdrawn | |
| UNSCA 45207N | Withdrawn | |
| UNSSA 45107 | Withdrawn | |
| UNSCA 45404H | Withdrawn | |
| UNSAA 404015AH | Withdrawn | |
| UNSHA 4047 | Withdrawn | |
| UNSCA 45304H | Withdrawn | |
| UNSHA 4524 | Withdrawn | |
| UNSSA 45204 | Withdrawn | |
| UNSSA 45207 | Withdrawn | |
| UNSMUA 485020N | Withdrawn | |
| UNSCA 45505H | Withdrawn | |
| UNSCA 40605N | Withdrawn | |
| UNSCA 40707H | Withdrawn | |
| UNSSA 45605 | Withdrawn | |
| UNSSA 40107 | Withdrawn | |
| UNSSA 45104 | Withdrawn | |
| UNSCA 40507N | Withdrawn | |
| UNSCA 40104H | Withdrawn | |
| UNSMUA 484020N | Withdrawn | |
| UNSCS 2730 | Withdrawn | |
| UNSSA 40704 | Withdrawn | |
| UNSCA 40307H | Withdrawn | |
| UNSMUA 483020H | Withdrawn | |
| UNSHA 4024 | Withdrawn | |
| UNSCA 45104N | Withdrawn | |
| UNSSA 45305 | Withdrawn | |
| UNSCA 40205H | Withdrawn | |
| UNSMUA 484020H | Withdrawn | |
| UNSSA 40405 | Withdrawn | |
| UNSCA 45404N | Withdrawn | |
| UNSCA 40704N | Withdrawn | |
| UNSCS 2710 | Withdrawn | |
| UNSSA 45707 | Withdrawn | |
| UNSKA 4801 | Withdrawn | |
| UNSTA 4030N | Withdrawn | |
| UNSCA 40505H | Withdrawn | |
| UNSMUA 482520H | Withdrawn | |
| UNSCA 40107H | Withdrawn | |
| UNSCA 45507N | Withdrawn | |
| UNSCA 40404N | Withdrawn | |
| UNSAA 404015N | Withdrawn | |
| UNSSA 45304 | Withdrawn | |
| UNSCA 45707H | Withdrawn | |
| UNSSA 45405 | Withdrawn | |
| UNSSA 45307 | Withdrawn | |
| UNSSA 45205 | Withdrawn | |
| UNSCA 40204H | Withdrawn | |
| UNSHA 4058 | Withdrawn | |
| UNSCA 45307N | Withdrawn | |
| UNSCA 45704N | Withdrawn | |
| UNSCS 2710S | Withdrawn | |
| UNSCA 45704H | Withdrawn | |
| UNSSA 45404 | Withdrawn | |
| UNSCA 45204H | Withdrawn | |
| UNSHA 4535 | Withdrawn | |
| UNSAS 1407H | Withdrawn | |
| UNSCS 2720 | Withdrawn | |
| UNSCA 45504N | Withdrawn | |
| UNSCA 45504H | Withdrawn | |
| UNSTA 4010H | Withdrawn | |
| UNSBA 3570 | Withdrawn | |
| UNSCA 40605H | Withdrawn | |
| UNSCA 45405H | Withdrawn | |
| UNSBA 3540 | Withdrawn | |
| UNSCA 45107N | Withdrawn | |
| UNSCA 40705N | Withdrawn | |
| UNSCA 45407N | Withdrawn | |
| UNSHA 4060 | Withdrawn | |
| UNSSA 40104 | Withdrawn | |
| UNSCA 40207N | Withdrawn | |
| UNSCA 45505N | Withdrawn | |
| UNSCA 40205N | Withdrawn | |
| UNSCA 40704H | Withdrawn | |
| UNSBA 3520 | Withdrawn | |
| UNSCA 40405H | Withdrawn | |
| UNSSA 45704 | Withdrawn | |
| UNSCA 45205H | Withdrawn | |
| UNSCA 40307N | Withdrawn | |
| UNSCA 40604H | Withdrawn | |
| UNSCA 40105H | Withdrawn | |
| UNSCA 45307H | Withdrawn | |
| UNSCA 40405N | Withdrawn | |
| UNSTA 4030H | Withdrawn | |
| UNSCA 45604N | Withdrawn | |
| UNSKA 4803 | Withdrawn | |
| UNSCA 45105N | Withdrawn | |
| UNSSA 45607 | Withdrawn | |
| UNSCA 40705H | Withdrawn | |
| UNSHA 4035 | Withdrawn | |
| UNSAA 402015BH | Withdrawn | |
| UNSSA 40505 | Withdrawn | |
| UNSSA 40507 | Withdrawn | |
| UNSCA 45305H | Withdrawn | |
| UNSCA 40505N | Withdrawn | |
| UNSAA 404015BH | Withdrawn | |
| UNSCA 45204N | Withdrawn | |
| UNSSA 40307 | Withdrawn | |
| UNSSA 40305 | Withdrawn | |
| UNSSA 40404 | Withdrawn | |
| UNSSA 45507 | Withdrawn | |
| UNSCA 40304H | Withdrawn | |
| UNSCA 45105H | Withdrawn | |
| UNSHA 4547 | Withdrawn | |
| UNSMUA 485020H | Withdrawn | |
| UNSSA 40407 | Withdrawn | |
| UNSSA 40605 | Withdrawn | |
| UNSCA 40604N | Withdrawn | |
| UNSCA 45205N | Withdrawn | |
| UNSCA 40105N | Withdrawn | |
| UNSSA 40304 | Withdrawn | |
| UNSCS 2700S | Withdrawn | |
| UNSCA 40305H | Withdrawn | |
| UNSCA 45605H | Withdrawn | |
| UNSCS 2730S | Withdrawn | |
| UNSHA 4020 | Withdrawn | |
| UNSSA 45407 | Withdrawn | |
| UNSCA 45604H | Withdrawn | |
| UNSMUA 483020N | Withdrawn | |
| UNSCA 40305N | Withdrawn | |
| UNSCA 40104N | Withdrawn | |
| UNSSA 40607 | Withdrawn | |
| UNSCA 40607H | Withdrawn |
Showing 250 of 286 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220253 | 2023-08-18 |
| K193404 | 2020-05-18 |
| K192263 | 2020-02-21 |
| K190048 | 2019-09-30 |
| K181037 | 2018-12-21 |
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.