Manufacturer registered with FDA
O&S Dental Inc
Chicago, IL, United States. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What O&S Dental Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | OrthoVita Etchant LiquidOrthoVita Light Cure Band CementOrthoVita Light Cure Orthodontic AdhesiveOrthoVita Light Cure Primer | 2019 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | — | 2020 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Tubules | 2019 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Maker | — | 2026 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Top Elastics, Top Chain, Top Sticks, Separators | 2019 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | — | 2020 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | Spring | 2020 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic Wax | 2019 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | — | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Orthodontic BandsOrthodontic Brackets | 2019 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | Orthodontic Scaler | 2019 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | — | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
O&S Dental Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prime Dental Manufacturing, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| O&S Dental, Inc.FDA reg. 3010065389 | Chicago, IL, United States | Manufacturer for export, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062113). 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.