Paltop
Paltop Conical Connection Dental Implant Dia 3.75mm L 11.5mm
7manufacturers in China registered for this device type
203catalogue numbers in this listing
7510(k) clearances naming this product code
2recalls on this code
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 | Paltop Advanced Dental Solutions Ltd, Israel |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K220200 |
| Record published | 2021-03-02 |
| Record revised | 2024-03-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 8 to 16 mm; outer diameter 3.25 to 5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 29-70027TC | In distribution | |
| 29-70006TC | In distribution | |
| 24-70016 | In distribution | |
| 24-70001 | In distribution | |
| 22-70011 | In distribution | |
| 20-70020 | Length 13 mm | In distribution |
| 29-70012 | In distribution | |
| 24-70017MC | In distribution | |
| 20-70016 | Outer Diameter 5 mm | In distribution |
| 20-70012P | In distribution | |
| 20-70027P | In distribution | |
| 21-70037 | In distribution | |
| 21-70003 | In distribution | |
| 20-70022 | In distribution | |
| 29-70003TC | In distribution | |
| 20-70017P | In distribution | |
| 29-70008TC | In distribution | |
| 24-70003 | In distribution | |
| 29-70003 | In distribution | |
| 24-70015 | In distribution | |
| 21-70013 | In distribution | |
| 24-70021MC | In distribution | |
| 21-70026 | In distribution | |
| 29-70025TC | In distribution | |
| 24-70006MC | In distribution | |
| 24-70009MC | In distribution | |
| 29-70015TC | In distribution | |
| 22-70018 | Outer Diameter 3.25 mm | In distribution |
| 29-70007TC | In distribution | |
| 20-70034P | In distribution | |
| 20-70025P | In distribution | |
| 24-70014 | In distribution | |
| 24-70004 | In distribution | |
| 21-70006 | In distribution | |
| 20-70005P | In distribution | |
| 24-70010 | In distribution | |
| 20-70014 | Outer Diameter 5 mm | In distribution |
| 20-70035 | In distribution | |
| 29-70026 | In distribution | |
| 29-70011 | In distribution | |
| 20-70022P | In distribution | |
| 29-70021TC | In distribution | |
| 24-70005MC | In distribution | |
| 20-70004 | Outer Diameter 3.75 mm | In distribution |
| 29-70010TC | In distribution | |
| 21-70008 | In distribution | |
| 29-70004TC | In distribution | |
| 20-70014P | In distribution | |
| 20-70010 | Length 16 mm | In distribution |
| 29-70007 | In distribution | |
| 29-70001TC | In distribution | |
| 24-70013 | In distribution | |
| 24-70016MC | In distribution | |
| 21-70005 | In distribution | |
| 22-70010 | Length 16 mm | In distribution |
| 20-70019 | Outer Diameter 3.25 mm | In distribution |
| 20-70019P | In distribution | |
| 22-70016 | Outer Diameter 5 mm | In distribution |
| 24-70020 | In distribution | |
| 29-70020 | In distribution | |
| 24-70007 | In distribution | |
| 24-70013MC | In distribution | |
| 29-70006 | In distribution | |
| 24-70021 | In distribution | |
| 20-70011P | In distribution | |
| 22-70007 | Outer Diameter 4.2 mm | In distribution |
| 29-70015 | In distribution | |
| 29-70005 | In distribution | |
| 20-70008P | In distribution | |
| 29-70010 | In distribution | |
| 20-70009 | Outer Diameter 4.2 mm | In distribution |
| 21-70010 | In distribution | |
| 29-70013 | In distribution | |
| 24-70006 | In distribution | |
| 20-70005 | In distribution | |
| 29-70024 | In distribution | |
| 20-70036P | In distribution | |
| 20-70001P | In distribution | |
| 24-70008MC | In distribution | |
| 29-70023 | In distribution | |
| 20-70015 | Length 13 mm | In distribution |
| 29-70020TC | In distribution | |
| 29-70009 | In distribution | |
| 24-70012MC | In distribution | |
| 21-70011 | In distribution | |
| 29-70016TC | In distribution | |
| 20-70023P | In distribution | |
| 20-70006 | Length 8 mm | In distribution |
| 24-70007MC | In distribution | |
| 20-70035P | In distribution | |
| 21-70016 | In distribution | |
| 21-70004 | In distribution | |
| 20-70013P | In distribution | |
| 29-70017TC | In distribution | |
| 20-70007P | In distribution | |
| 24-70001MC | In distribution | |
| 29-70002TC | In distribution | |
| 29-70019TC | In distribution | |
| 20-70037P | In distribution | |
| 21-70019 | Outer Diameter 3.25 mm | In distribution |
| 22-70009 | Outer Diameter 4.2 mm | In distribution |
| 29-70014TC | In distribution | |
| 20-70002 | Length 11.5 mm | In distribution |
| 20-70007 | Outer Diameter 4.2 mm | In distribution |
| 20-70020P | In distribution | |
| 22-70006 | Length 8 mm | In distribution |
| 20-70001 | Length 10 mm | In distribution |
| 29-70025 | In distribution | |
| 21-70015 | In distribution | |
| 22-70003 | Length 13 mm | In distribution |
| 24-70011MC | In distribution | |
| 20-70004P | In distribution | |
| 21-70024 | In distribution | |
| 20-70024P | In distribution | |
| 20-70013 | Length 10 mm | In distribution |
| 24-70009 | In distribution | |
| 22-70002 | Outer Diameter 3.75 mm | In distribution |
| 22-70021 | Length 16 mm | In distribution |
| 20-70003P | In distribution | |
| 24-70010MC | In distribution | |
| 29-70022 | In distribution | |
| 29-70013TC | In distribution | |
| 29-70012TC | In distribution | |
| 24-70002 | In distribution | |
| 29-70011TC | In distribution | |
| 24-70018MC | In distribution | |
| 24-70005 | In distribution | |
| 20-70036 | In distribution | |
| 24-70011 | In distribution | |
| 24-70012 | In distribution | |
| 20-70018 | Length 10 mm | In distribution |
| 22-70014 | Outer Diameter 5 mm | In distribution |
| 22-70020 | Outer Diameter 3.25 mm | In distribution |
| 20-70021 | Outer Diameter 3.25 mm | In distribution |
| 22-70001 | Length 10 mm | In distribution |
| 20-70016P | In distribution | |
| 29-70002 | In distribution | |
| 24-70020MC | In distribution | |
| 29-70005TC | In distribution | |
| 29-70017 | In distribution | |
| 24-70004MC | In distribution | |
| 24-70002MC | In distribution | |
| 29-70023TC | In distribution | |
| 24-70018 | In distribution | |
| 29-70009TC | In distribution | |
| 24-70019 | In distribution | |
| 20-70006P | In distribution | |
| 29-70021 | In distribution | |
| 29-70018TC | In distribution | |
| 29-70018 | In distribution | |
| 21-70027 | In distribution | |
| 24-70008 | In distribution | |
| 20-70017 | Outer Diameter 3.75 mm | In distribution |
| 21-70035 | In distribution | |
| 22-70008 | Length 11.5 mm | In distribution |
| 20-70012 | Outer Diameter 5 mm | In distribution |
| 20-70018P | In distribution | |
| 29-70014 | In distribution | |
| 21-70012 | In distribution | |
| 29-70001 | In distribution | |
| 20-70009P | In distribution | |
| 22-70013 | Length 10 mm | In distribution |
| 21-70034 | In distribution | |
| 22-70005 | In distribution | |
| 20-70002P | In distribution | |
| 21-70009 | In distribution | |
| 21-70017 | In distribution | |
| 21-70020 | Length 13 mm | In distribution |
| 22-70019 | Length 11.5 mm | In distribution |
| 21-70023 | In distribution | |
| 22-70004 | Outer Diameter 3.75 mm | In distribution |
| 29-70026TC | In distribution | |
| 20-70015P | In distribution | |
| 29-70027 | In distribution | |
| 22-70012 | Outer Diameter 5 mm | In distribution |
| 29-70024TC | In distribution | |
| 21-70014 | In distribution | |
| 29-70008 | In distribution | |
| 29-70016 | In distribution | |
| 21-70002 | In distribution | |
| 21-70036 | In distribution | |
| 20-70021P | In distribution | |
| 20-70008 | Length 11.5 mm | In distribution |
| 20-70037 | In distribution | |
| 20-70010P | In distribution | |
| 20-70011 | In distribution | |
| 24-70019MC | In distribution | |
| 24-70017 | In distribution | |
| 21-70018 | Length 10 mm | In distribution |
| 20-70003 | Length 13 mm | In distribution |
| 29-70004 | In distribution | |
| 22-70015 | Length 13 mm | In distribution |
| 24-70003MC | In distribution | |
| 21-70022 | In distribution | |
| 21-70001 | In distribution | |
| 29-70019 | In distribution | |
| 20-70026P | In distribution | |
| 21-70025 | In distribution | |
| 24-70014MC | In distribution | |
| 22-70017 | Length 8 mm | In distribution |
| 24-70015MC | In distribution | |
| 21-70007 | In distribution | |
| 29-70022TC | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243983 | 2025-09-29 |
| K232740 | 2024-05-22 |
| K220200 | 2022-05-25 |
| K210117 | 2021-11-30 |
| K130462 | 2013-08-27 |
| K131451 | 2013-08-22 |
| K112795 | 2012-04-20 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Paltop Advanced Dental Solutions Ltd | 510(k) number | 2019-11-18 | Class II | Mixed-up of materials/components | Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant. | 67 | 2022-12-27 |
| Paltop Advanced Dental Solutions Ltd | 510(k) number | 2019-05-30 | Class II | Under Investigation by firm | Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant. | 167 units | 2020-06-09 |
| Keystone Dental Inc. | 510(k) number | 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 13 kits hex Driver | 2020-06-19 |
| Keystone Dental Inc. | 510(k) number | 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 1 hex Driver | 2020-06-19 |
| Keystone Dental Inc. | 510(k) number | 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 3 hex Driver | 2020-06-19 |
| Keystone Dental Inc. | 510(k) number | 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 3 Hex Driver | 2020-06-19 |
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.