Manufacturer registered with FDA
Saga Dental Supply A
Kongsvinger, Norway. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1Norway
Registered in 3 markets
Where regulators' registries name Saga Dental Supply A 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 | Saga Dental Supply A | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Saga Dental Supply AS | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SAGA DENTAL SUPPLY AS | 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 Saga Dental Supply A currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | AlignerHerbstHerbst or MALUMALU | 2007 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Lister | Band | 2010 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Impression Tray | 2009 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | band | 2010 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | Band | 2007 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | clamp wire | 2007 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Lip and Cheek Retractor | 2007 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | BurDiamond Bur IPR | 2007 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | Pliers | 2007 |
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 |
|---|---|---|
| Saga Dental Supply ASFDA reg. 1000439711 | Kongsvinger Hedmark, Norway | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Saga Dental Supply AS
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023631). 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.