Manufacturer registered with FDA
MC Bio s.r.l.
Lomazzo, Italy. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 82
- 510(k) clearances
- 0as applicant
- Markets registered in
- 310 registrations outside the US
- Establishments
- 1Italy
Registered in 3 markets
Where regulators' registries name MC Bio s.r.l. 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 | MC Bio s.r.l. | 7 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | McBio s.r.l | 9 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | MC Bio s.r.l. | 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 MC Bio s.r.l. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | MC Bio Supertack tack 3mmMC Bio Supertack tack 4mmMC Bio Supertack tack 5mm | 2022 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Diamond Tissue Punch 10mmDiamond Tissue Punch 11.5mmDiamond Tissue Punch 12.5mmDiamond Tissue Punch 6mmDiamond Tissue Punch 8mmTip D. 2.7 | 2026 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | G-Special SetG-Special Set IIGBR Modular Tack SetHarv Tack SP SetMTAL Tack OrganizerTack DriverTack G-Special FY SetTip wrenchTUFF TACK SP set | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Needle tipNeedle tip -BLK | 2026 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Advanced SetAluminum Tack Placement InstrumentBack applicatorBack applicator tipBasic SetBLK Long tipBLK Offset tipBLK SP Long tipBLK SP Offset tipBLK SP tip 22 moreBLK Standard tipGBR Modular setHandle - Asym - ErgalHandle - Asym - SP (TiN)Handle - Asym - TitaniumHandle - Straight - ErgalHandle - Straight MDFHandle - Straight SP (TiN)Indexable StopLong tipLong tip SPMalletOffset tipOffset tip SPSpecialist OrganizerStainless Steel Tack Placement InstrumentStandard tipStarter SetTack OrganizerTip SPTip with Indexable StopTissue Punch Set | 2022 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | SCL Long TipSCL SP ApplicatorSCL Tip | 2026 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Blade - Asym. 2XL (9mm)Blade - Asym. 3XL (10mm)Blade - Asym. M (6mm)Blade - Asym. S (5mm)Blade - Asym. XL (8mm)Blade - Straight 2XL (9mm)Blade - Straight M (6mm)Blade - Straight S (5mm)Blade - Straight XL (8mm)CBR Scraper - Asymm. 2XL 17 moreCBR Scraper - Asymm. 3XLCBR Scraper - Asymm. MCBR Scraper - Asymm. SCBR Scraper - Asymm. XLCBR Scraper - Straight 2XLCBR Scraper - Straight MCBR Scraper - Straight SCBR Scraper - Straight XLTank & Blade - Asym. 2XL (9mm)Tank & Blade - Asym. 3XL (10mm)Tank & Blade - Asym. M (6mm)Tank & Blade - Asym. S (5mm)Tank & Blade - Asym. XL (8mm)Tank & Blade - Straight 2XL (9mm)Tank & Blade - Straight M (6mm)Tank & Blade - Straight S (5mm)Tank & Blade - Straight XL (8mm) | 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 |
|---|---|---|
| MC BIO S.R.L.FDA reg. 3022378059 | Lomazzo Como, Italy | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084869). 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.