Manufacturer registered with FDA
Gestenco International AB
Gothenburg, Sweden. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 4
- 510(k) clearances
- 12005–2005
- Markets registered in
- 522 registrations outside the US
- Establishments
- 1Sweden
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Gestenco International AB 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 | Gestenco International AB | 1 clearances | 2005–2005 | Below |
| United Kingdom | MHRA | Manufacturer | Gestenco International AB | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Gestenco International AB | 5 | 2004–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Gestenco International AB | 4 | 2003–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GESTENCO INTERNATIONAL AB | 1 | 2017–2017 | 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 Gestenco International AB 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 | — | Maker | — | 2007 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Springtime CVitrine | 2007 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Plucker Aligner RemoverRodneys Aligner Seaters | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | 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
Gestenco International AB 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: Gac Intl., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Apr 1999 | K981036 | SMARTBOND | Gac Intl., Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GESTENCO INTERNATIONAL ABFDA reg. 3004109528 | GOTEBORG Vastra Gotaland, Sweden | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9028524). 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.