Manufacturer registered with FDA
LX Precision Shanghai Co. Ltd.
Shanghai, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 33
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What LX Precision Shanghai Co. Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Biomet 3i Abutment Retaining ScrewsN/AZimmer Biomet-2X11MM SD IMF SCREW2X5MM SD IMF SCREW2X7MM SD IMF SCREW2X9MM SD IMF SCREW | 2013 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Biomet Microfixation OmniMax MMF SystemCMF SystemNeuro SystemTraumaOne System1.5mm System1.5X3.5MM HT SD X-DR SCR1.5X3.5MM X-DRIVE TF SD SCREW1.5X4MM HT SD X-DR SCR1.5X4MM X-DRIVE TF SD SCREW1.5X5MM HT SD X-DR SCR 7 more1.5X6MM HT SD X-DR SCR1.5X7MM HT SD X-DR SCR1.65 X 6MM SD X-DRIVE SCREW1.65 X 7MM HT SD X-DRIVE1.65X5MM HT SD X-DR SCR1mm System2mm System | 2018 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Biomet Microfixation OmniMax MMF System2 X 13MM IMF SCREW2X11MM T1 SD IMF SCREW2X15MM IMF SCREW2X7MM T1 SD IMF SCREW2X9MM T1 SD IMF SCREW | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BIOMET 3i Dental Abutments | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BIOMET 3i Dental Abutments | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LX PRECISION SHANGHAI CO LTDFDA reg. 3008791302 | Shanghai, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034962). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.