Manufacturer registered with FDA
DentalMaster (Xiamen) Medical Technology Co., Ltd.
Xiamen, China. Lists 24 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 24
- Brands and models
- 106
- 510(k) clearances
- 12026–2026
- Markets registered in
- 227 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name DentalMaster (Xiamen) Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DentalMaster (Xiamen) Medical Technology Co., Ltd. | 1 clearances | 2026–2026 | Below |
| European Union | EUDAMED | Manufacturer | DentalMaster(Xiamen) Medical Technology Co., Ltd. | 27 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DentalMaster (Xiamen) Medical Technology 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bone BurBone chiselBone DrillBone ExtractorBone HarvesterBone Harvesting DrillBone InserterBone MillBone SawBone Saw Disk 20 moreBone SpreaderDrillDrill BitFinal DrillImplant ConnectorImplant ExtenderLateral Approach Drill IVLimit DrillMachine ScrewdriverMachine Screwdriver IIMachine Screwdriver(long)Machine Screwdriver(short)Manual Screwdriverorthopedic DrillPilot DrillPositioning DrillS-ReamerTissue PunchTitanium Brushtrephine drill | 2026 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Guided Bone Regeneration System | 2026 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Carborundum burrCrestal Approach Drill ICrestal Approach Drill IILateral Approach Drill III | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Syringe Tip | 2026 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | Manual Screwdriver | 2026 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Angled bone clampBone ClampBone fragment forcepsBone HolderCutting ForcepForcep IForcep IIForcep IIIHolding ForcepManual Screwdriver 3 moreNeedle HolderTack ExtractorTissue Forceps | 2026 |
| ParallelometerEGI · Class 1 | Dental hand instruments | Maker | Drill Guide | 2026 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Bone fragment ForcepsDental Scissors | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Bone CarrierBone Condenser | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Mouth RetractorOral retractorPositioning RingStopperWound Retractor | 2026 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Gauge | 2026 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Bone Graft BowlBone Scraper (Angled)Bone Scraper (Straight)Bone Tack GunBone Tack Holder(Angled)Bone Tack Holder(Straight)Curved-type Tack HolderHandleHook-type Tack HolderImplant Connector 10 moreMachine WrenchProtective coverSaliver EjectorScalpel HandleScrew Holder(angled)Screw Holder(straight)Screwdriver GripperScrewdriver ProtectorStraight-type Tack HolderWrench | 2026 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Open DrillProbe | 2026 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | Dental Filler | 2026 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | PTFE Tape | 2026 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | PTFE Tape Press Instrument | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | PTFE Tape Removal Instrument | 2026 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Hemostatic Forceps | 2026 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Rongeur Forceps | 2026 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Elevator IElevator IIElevator IIIElevator IVPeriosteal SeparatorTack ExtractorW-tension Release Comb | 2026 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | BladeBlade (plastic)Dental BladeDental ExcavatorSmart Scraper | 2026 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Bone ChiselBone Splitting ChiselOsteotome V | 2026 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | Dental Scaler | 2026 |
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 |
|---|---|---|
| DENTALMASTER (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3049848767 | Xiamen Fujian, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096306). 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.