Manufacturer registered with FDA
CDM Center of Excellence Ltd.
Beijiing, China. Lists 23 dental device types with FDA across 1 registered establishment.
- Device types listed
- 23
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 543 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name CDM Center of Excellence Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | CDM Center of Excellence Ltd. | 23 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | CDM Center of Excellence Ltd. | 29 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CDM Center of Excellence Ltd. | 11 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CDM CENTER OF EXCELLENCE LTD. | 2 | 2016–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | CDM Center Of Excellence Ltd | 1 | — | 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 CDM Center of Excellence 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 | Drill, Dental, Intraoral | 2014 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Needle, Dental | 2019 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Instruments, Dental Hand | 2014 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Unit, Syringe, Air And/Or Water | 2014 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton, Roll | 2014 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2014 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Cup, Prophylaxis | 2017 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator, Oral Cavity | 2014 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Syringe, Restorative And Impression Material | 2014 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor, All Types | 2014 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Forceps, Rubber Dam Clamp | 2014 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bur, Dental | 2014 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Agent, Polishing, Abrasive, Oral Cavity | 2017 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Spreader, Pulp Canal Filling Material, Endodontic | 2014 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Plugger, Root Canal, Endodontic | 2014 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Broach, Endodontic | 2014 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | File, Bone, Surgical | 2014 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | TIP, RUBBER, ORAL HYGIENE | 2014 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Absorber, Saliva, Paper | 2014 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, Implant, Dental, Endosseous | 2014 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Unit, operative dental, accessories | 2014 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Dental Hygiene Kit | 2014 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | General Purpose Dental Tray | 2014 |
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 |
|---|---|---|
| CDM CENTER OF EXCELLENCE LTD.FDA reg. 3011210208 | Beijing, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047261). 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.