Stage 1 Implant System
43 catalogue numbers from RSR4812-2K, listed by Keystone Dental Inc., United States, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
43catalogue numbers in this listing
5510(k) clearances naming this product code
11recalls 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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K003226 |
| Record published | 2016-01-29 |
| Record revised | 2021-03-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSR4812-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3308-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4116-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4812-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4112-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3312-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3314-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4108-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4808-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4110-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4810-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW6308-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3314-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3308-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4814-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4116-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4808-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4814-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4112-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5512-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4816-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4114-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4114-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3312-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4108-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4810-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5514-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW4812-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4812-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5512-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4110-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4814-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3310-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4810-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5510-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5508-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR3310-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW6310-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5510-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4810-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4808-2K | Outer Diameter 3.3-6.3mm | In distribution |
| RSR4808-3K | Outer Diameter 3.3-6.3mm | In distribution |
| RSW5508-2K | Outer Diameter 3.3-6.3mm | 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 |
|---|---|
| K240966 | 2024-07-09 |
| K223814 | 2023-05-25 |
| K201334 | 2020-08-18 |
| K101545 | 2010-10-28 |
| K071070 | 2007-10-23 |
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 2018-05-01 | Class II | Error in labeling | The implants are mislabeled. | 72 | 2018-09-14 |
| 2018-03-13 | Class II | Error in labeling | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. | 19 | 2018-07-23 |
| 2017-10-16 | Class III | Labeling mix-ups | A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve. | 55 | 2019-04-17 |
| 2017-08-25 | Class II | Error in labeling | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06. | 20 | 2019-04-16 |
| 2017-06-16 | Class II | Unknown/Undetermined by firm | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | 72 | 2019-04-16 |
| 2017-03-09 | Class II | Labeling mix-ups | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | 59 units | 2017-07-05 |
| 2016-09-15 | Class II | Packaging process control | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) | 55 units | 2017-01-03 |
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.