Omnia SRL
FIDENZA Parma, IT
OMNIA SRL appears in FDA device records in FIDENZA Parma, IT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Omnia SRL in 2018.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004361903 | 3004361903 | OMNIA SRL | VIA F.DELNEVO 190, FIDENZA Parma 43036 IT | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- LYUAccessory, Surgical Apparel
- FYFCap, Surgical
- GBXCatheter, Irrigation
- NRUChair, Dental, Without Operative Unit
- KGTDrape, Adhesive, Aerosol
- KKXDrape, Surgical, Antimicrobial
- FXTFilm, Camera, Surgical
- NABGauze / Sponge,Nonresorbable For External Use
- LROGeneral Surgery Tray
- FYAGown, Surgical
- EGZHolder, Film, X-Ray
- DZNInstruments, Dental Hand
- FXXMask, Surgical
- DYNMouthpiece, Saliva Ejector
- OEANon-Surgical Gown
- FWZOperating Room Accessories Table Tray
- EMEPunch, Biopsy, Surgical
- FXOSuit, Surgical
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- BWNTable And Attachments, Operating-Room
- FSMTray, Surgical, Instrument
- NRDUnit, Operative Dental, Accessories
- EFSUnit, Oral Irrigation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1518-2021 | Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00, 32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00, 32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00, 32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00, 72.T1951.00, 72.T1952.00, 72.T1953.00 | Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain