Manufacturer registered with FDA
Exelint International Co
Redondo Beach, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8339 registrations outside the US
- Establishments
- 1United States
Registered in 8 markets
Where regulators' registries name Exelint International Co 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 | Exelint International Co | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Exelint International, Co. | 252 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | EXELINT INTERNATIONAL, CO. | 39 | 1999–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Exelint International Co | 21 | 2010–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Exelint International Co. | 18 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Exelint International, Co. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | EXELINT INTERNATIONAL CO.EXELINT International, Co. · Exelint International, Co. | 4 | 2002–2017 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | EXELINT INTERNATIONAL, CO. | 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 Exelint International Co currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Superject Sterile Disposable Dental Needles | 2017 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | EXEL 1ml Delivery Syringe | 2024 |
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
Exelint International Co 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: Exel Intl. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 1986 | K861150 | EXEL DENTAL NEEDLE | Exel Intl. | DZM Dental Needle |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EXELINT INTERNATIONAL, CO.FDA reg. 1035907 | Redondo Beach, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024414). 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.