ACE Surgical
ACE Surgical TRI-CAM Titanium Screw for 4.3 mm, 5.0 mm, and 6.0 mm (5-pack)
15manufacturers in China registered for this device type
20catalogue numbers in this listing
19510(k) clearances naming this product code
1recall
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 | Prismatik Dentalcraft, Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-24 |
| Record revised | 2023-08-22 (version 5) |
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 |
| Sizes | Height 8.3 to 10 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 30435060S | Height 10 mm | 5 | In distribution |
| 3043MUS | Height 9 mm | In distribution | |
| 30503 | Post Height, 3mm | In distribution | |
| 2045MU30 | Margin Height, 3mm | In distribution | |
| 2035MU30 | Margin Height, 3mm | In distribution | |
| 2035MU17 | Margin Height, 2mm | In distribution | |
| 3035MUA | Margin Height, 2mm | In distribution | |
| 3043MUA | Margin Height, 2mm | In distribution | |
| 30433 | Post Height, 3mm | In distribution | |
| 303560 | Post Height, 6mm | In distribution | |
| 3043MU17 | Margin Height, 3mm | In distribution | |
| 304360 | Post Height, 6mm | In distribution | |
| 2045MU17 | Margin Height, 2mm | In distribution | |
| 305060 | Post Height, 6mm | In distribution | |
| 3050MUA | Margin Height, 2mm | In distribution | |
| 3043MU30 | Margin Height, 4mm | In distribution | |
| 30353 | Post Height, 3mm | In distribution | |
| 2045MUA | Margin Height, 2mm | In distribution | |
| 3035S | Height 8.3 mm | 5 | In distribution |
| 2035MUA | Margin Height, 2mm | 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 |
|---|---|
| K252582 | 2025-11-18 |
| K240240 | 2024-07-12 |
| K231940 | 2024-05-15 |
| K231097 | 2023-11-14 |
| K223496 | 2023-09-26 |
| K191222 | 2019-08-05 |
| K170044 | 2017-06-06 |
| K160979 | 2016-11-04 |
| K151798 | 2015-11-16 |
| K151375 | 2015-10-07 |
| K143515 | 2015-10-01 |
| K141923 | 2015-01-06 |
| K142118 | 2014-11-25 |
| K142115 | 2014-11-13 |
| K141211 | 2014-10-22 |
| K121391 | 2012-12-10 |
| K120858 | 2012-12-06 |
| K121688 | 2012-10-12 |
| K100993 | 2010-12-28 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2025-09-30 | Class II | Employee error | Incorrect titanium screw, packaged with dental implant. | 208 units |
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.