Paltop
Nylon Ball Abutment Retentive Cap Standard - 1300gr, Transparent
70manufacturers in China registered for this device type
166catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous
Record
| Listed by | Paltop Advanced Dental Solutions Ltd, Israel |
|---|---|
| FDA product code | NDP |
| Device type | Accessories, Implant, Dental, Endosseous |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3980 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-11-30 |
| Record revised | 2024-11-19 (version 11) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Angle 20 ° |
| Distribution end date | 2024-10-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56-70022 | In distribution | |
| 80-70028 | In distribution | |
| 80-70045 | In distribution | |
| 56-72011 | In distribution | |
| 30-70501 | In distribution | |
| 30-70408 | In distribution | |
| 30-90002S | In distribution | |
| 60-70202 | In distribution | |
| 60-70230 | In distribution | |
| 30-70106 | In distribution | |
| 60-70088 | Final Depth Pin for 5.0 implant | In distribution |
| 80-70042 | In distribution | |
| 56-72046 | In distribution | |
| 30-70510 | In distribution | |
| 80-70030 | In distribution | |
| 60-70172 | In distribution | |
| 56-70025 | Angle 20 ° | In distribution |
| 80-70012 | In distribution | |
| 60-70211 | In distribution | |
| 56-70009 | In distribution | |
| 56-72004 | In distribution | |
| 56-70017 | In distribution | |
| 56-70006 | In distribution | |
| 30-70102 | In distribution | |
| 44-70031 | In distribution | |
| 30-70409 | In distribution | |
| 30-70108 | In distribution | |
| 60-70213 | In distribution | |
| 40-70065 | In distribution | |
| 60-70019 | In distribution | |
| 40-70112 | In distribution | |
| 60-70171 | In distribution | |
| 80-70006 | In distribution | |
| 40-70022 | In distribution | |
| 30-70508 | In distribution | |
| 30-70105 | In distribution | |
| 80-70035 | In distribution | |
| 60-70110 | In distribution | |
| 80-70099 | In distribution | |
| 60-70218 | In distribution | |
| 56-70021 | In distribution | |
| 80-70033 | In distribution | |
| 60-70245 | In distribution | |
| 80-70003 | In distribution | |
| 30-70103 | In distribution | |
| 56-70002 | In distribution | |
| 56-70030 | In distribution | |
| 30-70101 | In distribution | |
| 56-70024 | Angle 20 ° | In distribution |
| 60-70149 | In distribution | |
| 30-90002 | In distribution | |
| 30-70506 | In distribution | |
| 60-70019 | In distribution | |
| 30-70503 | In distribution | |
| 30-70109 | In distribution | |
| 30-90003S | In distribution | |
| 30-70104 | In distribution | |
| 44-70036 | In distribution | |
| 30-70021 | In distribution | |
| 56-70031 | In distribution | |
| 30-70516 | In distribution | |
| 80-70004 | In distribution | |
| 30-70509 | In distribution | |
| 30-90001S | In distribution | |
| 30-70404 | In distribution | |
| 30-70403 | In distribution | |
| 56-70033 | In distribution | |
| 30-70110 | In distribution | |
| 30-70616 | In distribution | |
| 60-70086 | Final Depth Pin for 3.75 implant | In distribution |
| 56-70049 | In distribution | |
| 56-72001 | In distribution | |
| 56-70016 | In distribution | |
| 80-70044 | In distribution | |
| 56-70047 | In distribution | |
| 30-70402 | In distribution | |
| 30-70507 | In distribution | |
| 30-70107 | In distribution | |
| 60-70116 | In distribution | |
| 30-70415 | In distribution | |
| 30-70521 | In distribution | |
| 44-70035 | In distribution | |
| 60-70208 | In distribution | |
| 44-70040 | In distribution | |
| 40-70081 | In distribution | |
| 56-70048 | In distribution | |
| 56-70043 | In distribution | |
| 30-70524 | In distribution | |
| 30-70414 | In distribution | |
| 60-70085 | Final Depth Pin for 3.25 implant | In distribution |
| 60-70214 | In distribution | |
| 60-70209 | In distribution | |
| 56-70027 | In distribution | |
| 30-70405 | In distribution | |
| 60-70204 | In distribution | |
| 56-70026 | In distribution | |
| 60-70210 | In distribution | |
| 80-70031 | In distribution | |
| 56-70005 | In distribution | |
| 30-70504 | In distribution | |
| 30-70523 | In distribution | |
| 30-70413 | In distribution | |
| 56-70045 | In distribution | |
| 44-70047 | In distribution | |
| 60-70215 | In distribution | |
| 30-70512 | In distribution | |
| 30-70522 | In distribution | |
| 30-70401 | In distribution | |
| 60-70119 | In distribution | |
| 30-70618 | In distribution | |
| 56-70013 | In distribution | |
| 60-70206 | In distribution | |
| 60-70015 | 1.5-2.0mm | In distribution |
| 80-70048 | In distribution | |
| 56-70044 | In distribution | |
| 80-70043 | In distribution | |
| 60-70142 | In distribution | |
| 40-70110 | In distribution | |
| 56-70023 | In distribution | |
| 60-70087 | Final Depth Pin for 4.2 implant | In distribution |
| 56-70010 | In distribution | |
| 60-70115 | In distribution | |
| 56-70046 | In distribution | |
| 80-70008 | In distribution | |
| 56-70029 | In distribution | |
| 80-70036 | In distribution | |
| 30-70412 | In distribution | |
| 44-70048 | In distribution | |
| 30-70511 | In distribution | |
| 30-70520 | In distribution | |
| 60-70207 | In distribution | |
| 60-70212 | In distribution | |
| 60-70216 | In distribution | |
| 30-70600 | In distribution | |
| 60-70205 | In distribution | |
| 80-70032 | In distribution | |
| 56-70014 | In distribution | |
| 56-70032 | In distribution | |
| 60-70217 | In distribution | |
| 30-70502 | In distribution | |
| 56-70028 | In distribution | |
| 30-70406 | In distribution | |
| 30-70525 | In distribution | |
| 60-70201 | In distribution | |
| 60-70203 | In distribution | |
| 40-70111 | In distribution | |
| 30-90003 | In distribution | |
| 80-70009 | In distribution | |
| 60-70200 | In distribution | |
| 30-70407 | In distribution | |
| 56-70042 | Withdrawn | |
| 40-70132 | Withdrawn | |
| 56-70041 | Withdrawn | |
| 40-70306 | Withdrawn | |
| 40-70289 | Withdrawn | |
| 40-70023 | Withdrawn | |
| 40-70284 | Withdrawn | |
| 40-70288 | Withdrawn | |
| 40-70283 | Withdrawn | |
| 40-70131 | Withdrawn | |
| 30-70505 | Withdrawn | |
| 40-70282 | Withdrawn | |
| 40-70305 | Withdrawn | |
| 40-70285 | Withdrawn | |
| 40-70286 | Withdrawn | |
| 40-70287 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accessories, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,379 |
| Accessories, Implant, Dental, Endosseous | Institut Straumann AG | 1,320 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 1,112 |
| Inclusive | Prismatik Dentalcraft, Inc. | 1,045 |
| Medentika | Medentika GmbH | 1,042 |
| BioHorizons | Biohorizons Implant Systems Inc. | 1,008 |
| IPD | Implant Protesis Dental 2004 SL | 998 |
| Klockner | Soadco, S.L. | 995 |
| Dynamic Abutment Solutions | Talladium España, SL | 877 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 738 |
| Nobel Biocare® | Nobel Biocare AB | 703 |
| MIS | MIS Implants Technologies Ltd. | 615 |
Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 782 | 2023-09-21 |
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 16 | 2023-09-21 |
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 236 | 2023-09-21 |
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 354 | 2023-09-21 |
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 68 | 2023-09-21 |
| 2021-07-26 | Class II | Process change control | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay | 337 | 2023-09-21 |
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.