Manufacturer registered with FDA
Sage Products, Inc.
Cary, IL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 11
- 510(k) clearances
- 11990–1990
- Markets registered in
- 743 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Sage Products, Inc. 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 | Sage Products, Inc. | 1 clearances | 1990–1990 | Below |
| United Kingdom | MHRA | Manufacturer | Sage Products LLC | 17 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Sage Products, LLCSage Products LLC | 12 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SAGE products LLC | 5 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sage Products LLC | 5 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Sage Products, LLCSAGE PRODUCTS INC | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SAGE PRODUCTS LLC | 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 Sage Products, 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | SageSage Self Oral Care | 2000 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Continue Care SystemsIndependent Care SystemPetite Short Term Swab SystemQ-Care RxQ-Care with Suction HandleQ-Care with Thumb PortSage Self Oral CareToothette Oral CareUltra-soft Toothbrush and Applicator Swab | 2008 |
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 |
|---|---|---|
| SAGE PRODUCTS LLCFDA reg. 1419181 | CARY, IL, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9914017). 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.