Neodent
Custom Abutment Angled Solution TI, FOR Neodent NGM. TI Screw
15manufacturers in China registered for this device type
1,308catalogue 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 | Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| 510(k) | K231803 |
| Record published | 2021-03-24 |
| Record revised | 2024-01-04 (version 7) |
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 | Special storage condition: Room temperature |
| Sizes | Height 0.3 to 22.05 mm; outer diameter 1.75 to 15.8 mm; angle 17 to 52 °; length 0.8 to 15.8 mm; width 4.5 to 6 mm; weight 11.3 to 19.7 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 114805 | Outer Diameter 3.3 mm | In distribution |
| 135.423 | Height 4.5 mm | In distribution |
| 116.296 | In distribution | |
| 114892 | Outer Diameter 4.5 mm | In distribution |
| 135377 | Outer Diameter 4.5 mm | In distribution |
| 106.213 | Height 0.8 mm | In distribution |
| 115.239 | Outer Diameter 4.8 mm | In distribution |
| 117.021 | In distribution | |
| 135.324 | Outer Diameter 6.5 mm | In distribution |
| 114868 | Length 1.5 mm | In distribution |
| 108.061 | Outer Diameter 3.3 mm | In distribution |
| 115.096 | Outer Diameter 5 mm | In distribution |
| 114.151 | Height 4 mm | In distribution |
| 116290 | Length 7.45 mm | In distribution |
| 135397 | Outer Diameter 6.5 mm | In distribution |
| 106236 | Outer Diameter 4.5 mm | In distribution |
| 135.216-ET | Outer Diameter 4.5 mm | In distribution |
| 114882 | Outer Diameter 6 mm | In distribution |
| 135.320 | Gingival Height 2.5 mm | In distribution |
| 106.211 | Outer Diameter 3.3 mm | In distribution |
| 135382 | Outer Diameter 5.5 mm | In distribution |
| 118.350 | Gingival Height 2.5 mm | In distribution |
| 114.155 | Height 0.8 mm | In distribution |
| 135.262 | Gingival Height 2.5 mm | In distribution |
| 114.387 | Height 1.5 mm | In distribution |
| 114.428 | Height 1 mm | In distribution |
| 114.922 | Height 3.5 mm | In distribution |
| 106.181 | Height 6.5 mm | In distribution |
| 114.169 | Outer Diameter 3.3 mm | In distribution |
| 114826 | Outer Diameter 3.3 mm | In distribution |
| 114.108 | Angle 30 ° | In distribution |
| 118.181 | Height 4 mm | In distribution |
| 114810 | Outer Diameter 4.5 mm | In distribution |
| 118.386 | Gingival height 3.5 | In distribution |
| 114.579 | Height 4 mm | In distribution |
| 115.166 | Angle 17 ° | In distribution |
| 135.204 | Height 4 mm | In distribution |
| 114.146 | Height 5.5 mm | In distribution |
| 114.575 | Height 6 mm | In distribution |
| 135.326 | Outer Diameter 6.5 mm | In distribution |
| 114.446 | Height 5.5 mm | In distribution |
| 115.094 | Outer Diameter 5 mm | In distribution |
| 135.314-ET | Gingival height 0.8 mm | In distribution |
| 135.252-ET | Outer Diameter 11.5 mm | In distribution |
| 135.194 | Height 3.5 mm | In distribution |
| 135.234 | Gingival Height 5.5 mm | In distribution |
| 114.425 | Height 1.5 mm | In distribution |
| 191.109 | In distribution | |
| 135.420-ET | Height 6 mm | In distribution |
| 102.073 | In distribution | |
| 115.200 | Height 1.5 mm | In distribution |
| 135364 | Outer Diameter 3.5 mm | In distribution |
| 106.202 | Height 3.5 mm | In distribution |
| 118.363-ET | Length 4.5 mm | In distribution |
| 102.106 | Height 5.5 mm | In distribution |
| 114814 | Outer Diameter 3.3 mm | In distribution |
| 118.380-ET | Outer Diameter 5 mm | In distribution |
| 135.367-ET | Outer Diameter 4.5 mm | In distribution |
| 114823 | Outer Diameter 4.5 mm | In distribution |
| 114900 | Outer Diameter 6 mm | In distribution |
| 115.145 | Height 5 mm | In distribution |
| 135.421 | Height 2.5 mm | In distribution |
| 114.755 | Angle 17 ° | In distribution |
| 135.316-ET | Gingival Height 2.5 mm | In distribution |
| 114845 | Outer Diameter 4.5 mm | In distribution |
| 135.380-ET | Outer Diameter 5.5 mm | In distribution |
| 114.399 | Outer Diameter 3.3 mm | In distribution |
| 114891 | Outer Diameter 4.5 mm | In distribution |
| 135.368-ET | Outer Diameter 4.5 mm | In distribution |
| 135.355-ET | Outer Diameter 3.5 mm | In distribution |
| 115.177 | Height 1.5 mm | In distribution |
| 114.480 | Height 4 mm | In distribution |
| 106.218 | Height 5.5 mm | In distribution |
| 118.381-ET | In distribution | |
| 114.535 | Outer Diameter 4.5 mm | In distribution |
| 135.258 | Height 1.5 mm | In distribution |
| 114862 | Length 1.5 mm | In distribution |
| 135.419-ET | Outer Diameter 3.5 mm | In distribution |
| 114.290 | Height 2.5 mm | In distribution |
| 135.412-ET | Outer Diameter 5.5 mm | In distribution |
| 102.145 | Height 3.5 mm | In distribution |
| 116.305 | Outer Diameter 2.35 mm | In distribution |
| 102.127 | Outer Diameter 4.3 mm | In distribution |
| 114806 | Outer Diameter 3.3 mm | In distribution |
| 135.131 | Height 4.5 mm | In distribution |
| 135.309-ET | Gingival height 0.8 mm | In distribution |
| 114.749 | Height 5.5 mm | In distribution |
| 135.365-ET | Outer Diameter 3.5 mm | In distribution |
| 106.222 | Outer Diameter 3.5 mm | In distribution |
| 114.395 | Angle 17 ° | In distribution |
| 114.759 | Height 2.5 mm | In distribution |
| 114.556 | Height 4 mm | In distribution |
| 116.2860-ET | Outer Diameter 1.85 mm | In distribution |
| 191.101 | In distribution | |
| 106.226 | Outer Diameter 5.5 mm | In distribution |
| 114.551 | Height 6 mm | In distribution |
| 135.241-ET | Gingival height 0.8 mm | In distribution |
| 115.299 | Angle 17 ° | In distribution |
| 114.577 | Height 6 mm | In distribution |
| 114.904 | Height 4 mm | In distribution |
| 114.391 | Height 2.5 mm | In distribution |
| 114.482 | Height 6 mm | In distribution |
| 114.117 | Outer Diameter 4.5 mm | In distribution |
| 114.481 | Height 6 mm | In distribution |
| 114841 | Outer Diameter 4.5 mm | In distribution |
| 114.398 | Height 3.5 mm | In distribution |
| 135.310 | Gingival Height 1.5 mm | In distribution |
| 115.294 | Gingival height 3.5 | In distribution |
| 191.045 | In distribution | |
| 114.743 | Height 5.5 mm | In distribution |
| 135.264 | Outer Diameter 3.5 mm | In distribution |
| 114.095 | Outer Diameter 4.5 mm | In distribution |
| 135.451-ET | Outer Diameter 4.5 mm | In distribution |
| 114.423 | Height 2.5 mm | In distribution |
| 135.211 | Height 3.5 mm | In distribution |
| 135.221 | Height 6 mm | In distribution |
| 135.465-ET | Outer Diameter 5.5 mm | In distribution |
| 135.243-ET | Gingival Height 2.5 mm | In distribution |
| 135374 | Outer Diameter 4.5 mm | In distribution |
| 114.432 | Height 6 mm | In distribution |
| 118.206 | Outer Diameter 4.1 mm | In distribution |
| 135362 | Outer Diameter 3.5 mm | In distribution |
| 135.403-ET | Outer Diameter 3.5 mm | In distribution |
| 135.426 | Gingival height 2.5 | In distribution |
| 135.212 | Height 4.5 mm | In distribution |
| 114.455 | Angle 17 ° | In distribution |
| 135.205 | Outer Diameter 3.5 mm | In distribution |
| 114.910 | Height 1.5 mm | In distribution |
| 115.259 | Height 4.5 mm | In distribution |
| 114842 | Outer Diameter 4.5 mm | In distribution |
| 191.044 | In distribution | |
| 114818 | Outer Diameter 3.3 mm | In distribution |
| 135.328 | Gingival Height 1.5 mm | In distribution |
| 114827 | Outer Diameter 3.3 mm | In distribution |
| 102.251 | Gingival Height 2.5 | In distribution |
| 114.406 | Angle 30 ° | In distribution |
| 114.741 | Height 3.5 mm | In distribution |
| 114.364 | Outer Diameter 3.3 mm | In distribution |
| 135.376-ET | Outer Diameter 4.5 mm | In distribution |
| 114.156 | Height 6 mm | In distribution |
| 114875 | Outer Diameter 4.5 mm | In distribution |
| 135.341 | Outer Diameter 5.5 mm | In distribution |
| 114.016 | Angle 17 ° | In distribution |
| 118.193 | Outer Diameter 3.3 mm | In distribution |
| 135.430 | Gingival height 2.5 | In distribution |
| 135368 | Outer Diameter 4.5 mm | In distribution |
| 114819 | Outer Diameter 3.3 mm | In distribution |
| 106.229 | Outer Diameter 7.0 mm | In distribution |
| 135.419 | Height 0.8 mm | In distribution |
| 114.026 | Height 3 mm | In distribution |
| 135.288 | Height 4.5 mm | In distribution |
| 115.258 | Height 3.5 mm | In distribution |
| 114811 | Outer Diameter 4.5 mm | In distribution |
| 114.858 | Angle 17 ° | In distribution |
| 135.444 | Height 3.5 mm | In distribution |
| 118.410 | Outer Diameter 4.8 mm | In distribution |
| 114.757 | Angle 17 ° | In distribution |
| 114825 | Outer Diameter 4.5 mm | In distribution |
| 114865 | Length 1.5 mm | In distribution |
| 102.249 | Gingival Height 0.2 | In distribution |
| 115.172 | Height 3 mm | In distribution |
| 114.459 | Angle 17 ° | In distribution |
| 118.288 | Outer Diameter 4.1 mm | In distribution |
| 135.305-ET | Gingival Height 1.5 mm | In distribution |
| 135.331 | Outer Diameter 4.0 mm | In distribution |
| 114833 | Outer Diameter 3.3 mm | In distribution |
| 114.889 | Gingival Height 2.5 mm | In distribution |
| 116.307-ET | In distribution | |
| 135.222 | Outer Diameter 4.5 mm | In distribution |
| 115.255 | Height 0.8 mm | In distribution |
| 135.441-ET | Height 4.5 mm | In distribution |
| 191.111 | In distribution | |
| 114.294 | Height 4 mm | In distribution |
| 114.390 | Outer Diameter 4.5 mm | In distribution |
| 135.308 | Outer Diameter 3.5 mm | In distribution |
| 114.341 | Height 2.5 mm | In distribution |
| 114.286 | Height 1.5 mm | In distribution |
| 191.114 | In distribution | |
| 114.050 | Outer Diameter 4.3 mm | In distribution |
| 106267 | In distribution | |
| 135.328-ET | Outer Diameter 4.0 mm | In distribution |
| 135.202 | Height 4 mm | In distribution |
| 115.211 | Angle 30 ° | In distribution |
| 114.083 | Outer Diameter 4.5 mm | In distribution |
| 118.082-ET | Outer Diameter 4.1 mm | In distribution |
| 135412 | Outer Diameter 5.5 mm | In distribution |
| 114.150 | Height 4 mm | In distribution |
| 135.309 | Outer Diameter 4.5 mm | In distribution |
| 135.282 | Height 4.5 mm | In distribution |
| 135.240 | Outer Diameter 6.0 mm | In distribution |
| 115.164 | Height 5.5 mm | In distribution |
| 114878 | Outer Diameter 4.5 mm | In distribution |
| 116.304-ET | Outer Diameter 2.35 mm | In distribution |
| 114.393 | Height 1.5 mm | In distribution |
| 115.143 | Angle 30 ° | In distribution |
| 114.926 | Height 3.5 mm | In distribution |
| 116.306 | Outer Diameter 2.35 mm | In distribution |
| 115279 | Length 2.5 mm | In distribution |
| 102.247 | Gingival Height 2.5 | In distribution |
| 114.903 | Outer Diameter 3.3 mm | In distribution |
| 108.246 | In distribution | |
| 135.445 | Height 4.5 mm | In distribution |
| 102.131 | Height 5 mm | In distribution |
| 114.359 | Height 3.5 mm | In distribution |
| 135.364-ET | Outer Diameter 3.5 mm | In distribution |
| 115.249 | Height 1.5 mm | In distribution |
| 135.236 | Outer Diameter 4.0 mm | In distribution |
| 114.860 | Gingival Height 1.5 mm | In distribution |
| 135385 | Outer Diameter 5.5 mm | In distribution |
| 115.182 | Height 2.5 mm | In distribution |
| 114869 | Length 2.5 mm | In distribution |
| 106.209 | Outer Diameter 3.3 mm | In distribution |
| 135.457 | Weight 19.7 g | In distribution |
| 135.268 | Height 2.5 mm | In distribution |
| 106.172 | Height 2.5 mm | In distribution |
| 118.385 | Gingival height 2.5 | In distribution |
| 135.304 | Gingival height 0.8 mm | In distribution |
| 114870 | Length 3.5 mm | In distribution |
| 106253 | Length 4.5 mm | In distribution |
| 116.294-ET | In distribution | |
| 135.319-ET | Gingival Height 1.5 mm | In distribution |
| 115.181 | Height 1.5 mm | In distribution |
| 135.231 | Gingival Height 2.5 mm | In distribution |
| 135.323 | Gingival Height 1.5 mm | In distribution |
| 114816 | Outer Diameter 3.3 mm | In distribution |
| 115.242 | Outer Diameter 4.8 mm | In distribution |
| 114.537 | Height 1.5 mm | In distribution |
| 135.393-ET | Outer Diameter 6.5 mm | In distribution |
| 115.295 | Gingival height 4.5 | In distribution |
| 102.071 | Height 3.5 mm | In distribution |
| 115.173 | Height 4 mm | In distribution |
| 118.391 | Height 4.6 mm | In distribution |
| 102.255 | Angle 30 ° | In distribution |
| 106.187 | Height 1.5 mm | In distribution |
| 106.185 | Height 6.5 mm | In distribution |
| 114.925 | Height 4.5 mm | In distribution |
| 115.260 | Height 5.5 mm | In distribution |
| 115.150 | Height 2.5 mm | In distribution |
| 114.102 | Height 4 mm | In distribution |
| 135.217-ET | Outer Diameter 4.5 mm | In distribution |
| 115.210 | Angle 30 ° | In distribution |
| 135.223-ET | Height 3.5 mm | In distribution |
| 115.078 | Angle 17 ° | In distribution |
| 135.322-ET | Outer Diameter 6.5 mm | In distribution |
| 114.132 | Height 0.8 mm | In distribution |
| 191.112 | In distribution | |
| 114.919 | Height 4.5 mm | In distribution |
| 114.559 | Height 6 mm | In distribution |
| 114.141 | Height 6.5 mm | In distribution |
| 102.248 | Gingival Height 3.5 | In distribution |
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 |
| 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 |
| Inclusive | Prismatik Dentalcraft, Inc. | 1,032 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261147 | 2026-07-01 |
| K253922 | 2026-06-15 |
| K252727 | 2026-01-07 |
| K233857 | 2024-05-02 |
| K231803 | 2023-12-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Straumann USA, LLC | UDI-DI | 2018-10-02 | Class II | Employee error | Laser engraved label does not match with the item in the package | 21 units | 2019-01-28 |
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.