Manufacturer registered with FDA
Med2B Ltd.
Kitzingen, Germany. Lists 20 dental device types with FDA across 1 registered establishment.
- Device types listed
- 20
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name Med2B 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 | Med2B Ltd. | 20 device types | — | Below |
| Brazil | ANVISA | Manufacturer | MED 2B LTD. | 1 | 2023–2023 | 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 Med2B 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2025 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | PUSHER, BAND, ORTHODONTIC | 2025 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | 2025 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | CARVER, WAX, DENTAL | 2025 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC | 2025 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Pliers, operative | 2025 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | KNIFE, MARGIN FINISHING, OPERATIVE | 2025 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | EXPLORER, OPERATIVE | 2025 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | INSTRUMENT, CUTTING, OPERATIVE | 2025 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE | 2025 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | 2025 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | CARRIER, AMALGAM, OPERATIVE | 2025 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | HEMOSTAT, SURGICAL | 2025 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPS, TOOTH EXTRACTOR, SURGICAL | 2025 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | FORCEPS, RONGEUR, SURGICAL | 2025 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | FILE, BONE, SURGICAL | 2025 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | CHISEL, BONE, SURGICAL | 2025 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2025 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | FILE, PERIODONTIC | 2025 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 2025 |
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 |
|---|---|---|
| MED2B LTD.FDA reg. 3035708926 | Kitzingen Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092562). 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.