UF(II) Implant System
TiN Coated Solid abutment
15manufacturers in China registered for this device type
431catalogue 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) | K170608 |
| Record published | 2018-08-24 |
| 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 |
|---|---|---|
| MASC 2006 | In distribution | |
| SSSA 45307 | In distribution | |
| SSSA 75304 | In distribution | |
| SSCA 45404H(II) | In distribution | |
| SSCA 75304H(II) | In distribution | |
| UNSSA 40707 | In distribution | |
| UNSSA 40405 | In distribution | |
| SSSA 55407 | In distribution | |
| SSCA 45204N(II) | In distribution | |
| SSCA 65105H(II) | In distribution | |
| SSCA 75504N(II) | In distribution | |
| SSCA 45107N(II) | In distribution | |
| SSCS 3410S | In distribution | |
| SSCA 55104H(II) | In distribution | |
| UNSSA 40205 | In distribution | |
| SSCA 65507N(II) | In distribution | |
| SSSA 75505 | In distribution | |
| UNSSA 45207 | In distribution | |
| SSCA 55204H(II) | In distribution | |
| SSCA 65207H(II) | In distribution | |
| SSCA 65405H(II) | In distribution | |
| SSSA 65505 | In distribution | |
| SSCA 55207H(II) | In distribution | |
| SSCA 45207H(II) | In distribution | |
| SSCA 55505N(II) | In distribution | |
| SSCA 65305N(II) | In distribution | |
| SSSA 75407 | In distribution | |
| SSSA 65204 | In distribution | |
| SSCA 65504H(II) | In distribution | |
| UNSSA 45507 | In distribution | |
| SSCA 55207N(II) | In distribution | |
| SSCS 3400S | In distribution | |
| SSCA 75105N(II) | In distribution | |
| SSSA 65405 | In distribution | |
| UNSSA 45704 | In distribution | |
| SSCA 75404H(II) | In distribution | |
| SSSA 65504 | In distribution | |
| SSCA 65404N(II) | In distribution | |
| MSA 4804 | In distribution | |
| UNSSA 45705 | In distribution | |
| SSSA 75104 | In distribution | |
| SSCA 75305N(II) | In distribution | |
| SSSA 75405 | In distribution | |
| SSCA 75205H(II) | In distribution | |
| SSCA 75204N(II) | In distribution | |
| UCA 4802 | In distribution | |
| SSCA 65504N(II) | In distribution | |
| UNSSA 45104 | In distribution | |
| SSSA 65304 | In distribution | |
| SSCA 65305H(II) | In distribution | |
| UCA 4801 | In distribution | |
| SSCA 55305N(II) | In distribution | |
| SSCA 65507H(II) | In distribution | |
| UNSSA 40207 | In distribution | |
| SSSA 55305 | In distribution | |
| UNSSA 45407 | In distribution | |
| SSCA 75307N(II) | In distribution | |
| UNSSA 45405 | In distribution | |
| SSSA 55204 | In distribution | |
| MSA 4801 | In distribution | |
| SSSA 75404 | In distribution | |
| SSCA 55405N(II) | In distribution | |
| SSCA 45404N(II) | In distribution | |
| SSCA 55505H(II) | In distribution | |
| SSSA 55304 | In distribution | |
| SSCA 65104H(II) | In distribution | |
| SSCA 55405H(II) | In distribution | |
| SSSA 65307 | In distribution | |
| SSCA 45407H(II) | In distribution | |
| SSCA 55204N(II) | In distribution | |
| SSCA 45204H(II) | In distribution | |
| UNSSA 45107 | In distribution | |
| SSCA 65204H(II) | In distribution | |
| UNSSA 40607 | In distribution | |
| SSSA 45107 | In distribution | |
| SSSA 45507 | In distribution | |
| SSSA 55504 | In distribution | |
| SSSA 45304 | In distribution | |
| UNSSA 40305 | In distribution | |
| SSCA 55504H(II) | In distribution | |
| SSSA 65107 | In distribution | |
| SSCA 75405N(II) | In distribution | |
| SSCA 55507N(II) | In distribution | |
| SSCS 3420S | In distribution | |
| SSCA 45205N(II) | In distribution | |
| SSSA 65105 | In distribution | |
| SSCA 65107N(II) | In distribution | |
| SSSA 75204 | In distribution | |
| SSSA 45105 | In distribution | |
| SSCA 65304H(II) | In distribution | |
| UNSSA 45305 | In distribution | |
| SSSA 45305 | In distribution | |
| SSCA 45305H(II) | In distribution | |
| SSCA 75505N(II) | In distribution | |
| SSCA 45305N(II) | In distribution | |
| SSCA 75204H(II) | In distribution | |
| SSCA 45405H(II) | In distribution | |
| SSCA 55107N(II) | In distribution | |
| SSCA 45507H(II) | In distribution | |
| SSCA 65205H(II) | In distribution | |
| SSCA 45507N(II) | In distribution | |
| SSCA 45504N(II) | In distribution | |
| SSCA 55105N(II) | In distribution | |
| SSSA 65104 | In distribution | |
| SSCA 45304H(II) | In distribution | |
| SSSA 75207 | In distribution | |
| SSCA 55107H(II) | In distribution | |
| UNSSA 40407 | In distribution | |
| SSSA 45504 | In distribution | |
| SSSA 65305 | In distribution | |
| SSCA 55305H(II) | In distribution | |
| UNSSA 45607 | In distribution | |
| SSCA 55407H(II) | In distribution | |
| SSCA 65407N(II) | In distribution | |
| SSCA 75505H(II) | In distribution | |
| SSSA 65407 | In distribution | |
| UNSSA 45505 | In distribution | |
| SSCA 45107H(II) | In distribution | |
| SSSA 45204 | In distribution | |
| SSSA 65207 | In distribution | |
| SSCA 55205N(II) | In distribution | |
| SSCA 65207N(II) | In distribution | |
| SSCA 75305H(II) | In distribution | |
| SSHA 5520 | In distribution | |
| SSCA 75307H(II) | In distribution | |
| SSCA 75407N(II) | In distribution | |
| SSSA 55507 | In distribution | |
| SSCA 65407H(II) | In distribution | |
| SSCA 65204N(II) | In distribution | |
| SSSA 75507 | In distribution | |
| SSCA 55404N(II) | In distribution | |
| UNSSA 40605 | In distribution | |
| SSCA 65205N(II) | In distribution | |
| SSCA 65307H(II) | In distribution | |
| SSCA 65405N(II) | In distribution | |
| SSSA 45505 | In distribution | |
| SSCA 75507N(II) | In distribution | |
| SSCA 75107H(II) | In distribution | |
| UCA 4803 | In distribution | |
| SSCA 75104N(II) | In distribution | |
| SSCA 45307N(II) | In distribution | |
| UNSSA 40307 | In distribution | |
| SSSA 45404 | In distribution | |
| SSSA 45207 | In distribution | |
| SSCA 55404H(II) | In distribution | |
| UNSSA 40507 | In distribution | |
| UNSSA 45604 | In distribution | |
| SSCA 75405H(II) | In distribution | |
| UNSSA 45404 | In distribution | |
| SSCA 45104H(II) | In distribution | |
| UNSSA 45205 | In distribution | |
| SSSA 45405 | In distribution | |
| SSSA 75305 | In distribution | |
| UNSSA 45605 | In distribution | |
| SSCA 45307H(II) | In distribution | |
| SSCA 45207N(II) | In distribution | |
| SSCA 55507H(II) | In distribution | |
| SSCA 65505H(II) | In distribution | |
| MSA 4803 | In distribution | |
| SSSA 55505 | In distribution | |
| SSCA 75205N(II) | In distribution | |
| SSCA 65304N(II) | In distribution | |
| SSCA 45205H(II) | In distribution | |
| UNSSA 40705 | In distribution | |
| SSCA 45407N(II) | In distribution | |
| SSSA 45104 | In distribution | |
| SSCA 65404H(II) | In distribution | |
| SSSA 55104 | In distribution | |
| SSCA 75507H(II) | In distribution | |
| SSCA 55304N(II) | In distribution | |
| SSHA 7520 | In distribution | |
| SSCA 55304H(II) | In distribution | |
| SSCA 75207H(II) | In distribution | |
| SSSA 45205 | In distribution | |
| SSSA 55404 | In distribution | |
| UNSSA 45307 | In distribution | |
| SSSA 45407 | In distribution | |
| SSCA 75105H(II) | In distribution | |
| SSCA 65104N(II) | In distribution | |
| SSCA 55104N(II) | In distribution | |
| SSCA 45504H(II) | In distribution | |
| SSSA 75205 | In distribution | |
| SSSA 65507 | In distribution | |
| DASC 2008H | In distribution | |
| SSCA 75407H(II) | In distribution | |
| SSCA 45505N(II) | In distribution | |
| UNSSA 45504 | In distribution | |
| SSCA 75304N(II) | In distribution | |
| SSCA 45105H(II) | In distribution | |
| SSSA 75107 | In distribution | |
| SSCA 75107N(II) | In distribution | |
| SSCA 65307N(II) | In distribution | |
| UNSSA 45707 | In distribution | |
| UNSSA 45105 | In distribution | |
| SSSA 65404 | In distribution | |
| SSCA 55205H(II) | In distribution | |
| MSA 4802 | In distribution | |
| SSHA 4520 | In distribution | |
| UNSSA 40107 | In distribution | |
| SSSA 55405 | In distribution | |
| SSCA 75404N(II) | In distribution | |
| SSSA 55205 | In distribution | |
| SSCA 65107H(II) | In distribution | |
| SSSA 55207 | In distribution | |
| SSCA 45105N(II) | In distribution | |
| SSSA 75504 | In distribution | |
| SSSA 55307 | In distribution | |
| SSCA 45104N(II) | In distribution | |
| SSCA 55307N(II) | In distribution | |
| SSCS 3430S | In distribution | |
| SSCA 55307H(II) | In distribution | |
| SSCA 55407N(II) | In distribution | |
| SSCA 65505N(II) | In distribution | |
| SSCA 45505H(II) | In distribution | |
| SSCA 55504N(II) | In distribution | |
| SSCA 75104H(II) | In distribution | |
| SSSA 55107 | In distribution | |
| SSCA 75504H(II) | In distribution | |
| SSSA 55105 | In distribution | |
| SSSA 65205 | In distribution | |
| SSCA 45405N(II) | In distribution | |
| UNSSA 40105 | In distribution | |
| SSCA 75207N(II) | In distribution | |
| SSCA 65105N(II) | In distribution | |
| SSSA 75307 | In distribution | |
| SSCA 55105H(II) | In distribution | |
| SSHA 6520 | In distribution | |
| SSCA 45304N(II) | In distribution | |
| SSSA 75105 | In distribution | |
| SSCA 55507H(II) | Withdrawn | |
| SSSA 75104 | Withdrawn | |
| SSSA 45104 | Withdrawn | |
| SSCA 75304N(II) | Withdrawn | |
| SSCA 65105N(II) | Withdrawn | |
| SSSA 45307 | Withdrawn | |
| SSCA 65307H(II) | Withdrawn | |
| SSCA 55404H(II) | Withdrawn | |
| SSSA 75407 | Withdrawn | |
| SSSA 55407 | Withdrawn | |
| SSHA 4520 | Withdrawn | |
| SSCA 65304H(II) | Withdrawn | |
| SSCA 75105H(II) | Withdrawn | |
| SSCA 45107N(II) | Withdrawn | |
| SSCA 45504H(II) | Withdrawn | |
| SSSA 65404 | Withdrawn | |
| SSCA 65107N(II) | Withdrawn | |
| SSSA 65407 | Withdrawn | |
| SSCA 55104H(II) | Withdrawn | |
| SSCA 55204N(II) | Withdrawn | |
| SSCA 65405N(II) | Withdrawn |
Showing 250 of 300 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.