Data / Medical devices / Italy / Rhein 83 SRL
Rhein 83 SRL: FDA-registered device maker in BOLOGNA Emilia-Romagna, Italy, 4 510(k) clearances
Rhein 83 SRL is registered with the FDA (registration 9680939) in BOLOGNA Emilia-Romagna, Italy. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 9, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680939
- FEI number
- 3002807996
- Address
- VIA EMILIO ZAGO 10abc, BOLOGNA Emilia-Romagna, Italy, 40128
- Owner or operator
- RHEIN83 SRL (9012485)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 22, 1995
- Registered through
- 2026
- Brand names listed
- 008MBG-IQ GINGIVA HEIGHT MEASURER, 008MDS SPHERE MEASURER, 008MDS-IQ SPHERE MEASURER, 010PSP18 PIVOT CASTABLE NORMO GREEN h10 #20, 027CRGUS OT BAR YELLOW CLIP MEDIUM 1.8KG #6, 030AEV541 OT EQUATOR ASTRA EV ø5,4 h.1, 030AEV542 OT EQUATOR ASTRA EV ø5,4 h.2, 030AS4NC3-DIO DIO Implant UF-UFII Regular Int. Type and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Anchor, Preformed | EJX | 1 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | K171409 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| August 11, 2016 | K160382 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| November 25, 2015 | K142211 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| April 21, 2004 | K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK | DZE | Substantially Equivalent | Rhein 83 Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Anchor, Preformed
- All makers of Post, Root Canal
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Drill, Dental, Intraoral
- All makers of Attachment, Precision, All
Updated April 9, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.