Data / Medical devices / United States / O&S Dental, Inc.
O&S Dental, Inc.: FDA-registered device maker in Chicago, IL, United States, 1 510(k) clearance
O&S Dental, Inc. is registered with the FDA (registration 3010065389) in Chicago, IL, United States. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010065389
- Address
- 6620 W Belmont Ave, Chicago, IL, United States, 60634
- Owner or operator
- O&S Dental Inc (10062113)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- December 19, 2019
- Registered through
- 2026
- Brand names listed
- OrthoVita Etchant Liquid, OrthoVita Light Cure Band Cement, OrthoVita Light Cure Orthodontic Adhesive, OrthoVita Light Cure Primer, Orthodontic Bands, Orthodontic Brackets, Orthodontic Scaler, Orthodontic Tubules and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Intraoral | EAP | 2 | Manufacturer for export | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer for export | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 24, 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wax, Dental, Intraoral
- All makers of Instrument, Ligature Tucking, Orthodontic
- All makers of Tube, Orthodontic
- All makers of Spring, Orthodontic
- All makers of Band, Elastic, Orthodontic
- All makers of Band, Preformed, Orthodontic
Updated October 24, 2001. 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.