O-Ring
The FDA filing lists O-Ring as one of the ball abutment designs in the Preat Abutments system. Preat Abutments are intended for use with endosseous dental implants in the maxilla or…
The FDA filing lists O-Ring as one of the ball abutment designs in the Preat Abutments system.
Preat Abutments are intended for use with endosseous dental implants in the maxilla or mandible to support single-unit or multi-unit prosthetic restorations.
Listed Item
BioHorizons®-compatible 3.5mm X 4.5mm Non-Engaging Titanium Base
Abutment Design
The summary describes the O-Ring as a ball configuration and states that the system also includes corresponding abutment screws. The subject abutment platform diameters range from 3.0 mm to 6.5 mm.
15manufacturers in China registered for this device type
78catalogue numbers in this listing
3510(k) clearances naming this product code
9recalls on this 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 | Preat Corporation, United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K183518 |
| Record published | 2022-06-28 |
| Record revised | 2024-02-09 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1708004 | In distribution | |
| 1600825 | In distribution | |
| 1600821 | In distribution | |
| 1700603 | In distribution | |
| 1701402 | In distribution | |
| 1705402 | In distribution | |
| 1700601 | In distribution | |
| 1705401 | In distribution | |
| 1705602 | In distribution | |
| 1700902 | In distribution | |
| 1701406 | In distribution | |
| 1700556 | In distribution | |
| 1701201 | In distribution | |
| 1708003 | In distribution | |
| 1701505 | In distribution | |
| 1600824 | In distribution | |
| 1600823 | In distribution | |
| 1705405 | In distribution | |
| 1700575 | In distribution | |
| 1701204 | In distribution | |
| 1700503 | In distribution | |
| 1700554 | In distribution | |
| 1708001 | In distribution | |
| 1701403 | In distribution | |
| 1701404 | In distribution | |
| 1700905 | In distribution | |
| 1701601 | In distribution | |
| 1701603 | In distribution | |
| 1700402 | In distribution | |
| 1700571 | In distribution | |
| 1708006 | In distribution | |
| 1700553 | In distribution | |
| 1705604 | In distribution | |
| 1705404 | In distribution | |
| 1700576 | In distribution | |
| 1701701 | In distribution | |
| 1700500 | In distribution | |
| 1700505 | In distribution | |
| 8005459 | In distribution | |
| 1701703 | In distribution | |
| 1700602 | In distribution | |
| 1705603 | In distribution | |
| 1702101 | In distribution | |
| 1700604 | In distribution | |
| 1700574 | In distribution | |
| 1701401 | In distribution | |
| 1701503 | In distribution | |
| 1708005 | In distribution | |
| 1700903 | In distribution | |
| 1700405 | In distribution | |
| 1700506 | In distribution | |
| 1701200 | In distribution | |
| 1701203 | In distribution | |
| 1705403 | In distribution | |
| 1700403 | In distribution | |
| 1702103 | In distribution | |
| 1701504 | In distribution | |
| 1700573 | In distribution | |
| 1701500 | In distribution | |
| 1705605 | In distribution | |
| 1700901 | In distribution | |
| 1702203 | In distribution | |
| 1701405 | In distribution | |
| 1700605 | In distribution | |
| 1701501 | In distribution | |
| 1700904 | In distribution | |
| 1700401 | In distribution | |
| 1701202 | In distribution | |
| 1700404 | In distribution | |
| 1700501 | In distribution | |
| 1705606 | In distribution | |
| 1700551 | In distribution | |
| 1700552 | In distribution | |
| 1700572 | In distribution | |
| 1700400 | In distribution | |
| 1800000 | In distribution | |
| 1705406 | In distribution | |
| 1702201 | In distribution |
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 |
|---|---|
| K243824 | 2025-05-08 |
| K220823 | 2022-10-26 |
| K183518 | 2019-03-18 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|
| Preat Corporation | 510(k) number | 2025-06-25 | Class II | Process control | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correc | 11 |
| Preat Corporation | 510(k) number | 2025-04-02 | Class II | Process control | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant. | 145 abutments |
| Preat Corporation | 510(k) number | 2024-02-09 | Class II | Process change control | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. | 561 units |
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 |
|---|---|---|---|---|
| 2025-06-24 | Class II | Employee error | Due to manufacturing error, digital analog rotational feature is 180 degrees off. | 44 units |
| 2024-04-10 | Class II | Process control | Due to incorrect milled titanium abutment being packaged and labeled. | 7 abutmens |
| 2023-07-18 | Class II | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | 13 units |
| 2023-07-18 | Class II | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | 23 units |
| 2023-07-18 | Class II | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | 4 units |
| 2023-02-21 | Class II | Process design | Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutmen | 26 |
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.