Not currently registered with FDA under this name
Datum Dental, Ltd.
Yavne Centra, Israel. Named as applicant on 5 dental 510(k) clearances between 2016 and 2026. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 52016–2026
- Markets registered in
- 1266 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Datum Dental, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Datum Dental, Ltd. | 5 clearances | 2016–2026 | Below |
| Colombia | INVIMA | Registration holder | DATUM DENTAL LTD.DATUM DENTAL LTDA · DATUM DENTAL LTD | 29 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Datum Dental Ltd. | 9 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DATUM DENTAL LTD. | 5 | 2015–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Datum Dental Ltd. | 5 | 2016–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Datum Dental Ltd | 4 | 2021–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Datum Dental Ltd. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DATUM DENTAL LTD. | 3 | 2022–2022 | Pure Global AI |
| China | NMPA | Registration holder | 达特沐牙科有限公司Datum Dental Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Datum Dental Ltd. | 2 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Datum Dental Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Datum Dental Ltd. | 1 | 2009–2009 | 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
510(k) clearances
Clearances on which FDA names Datum Dental, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Oct 2026 | K262415 | OSSIX Plus | NPL Intraoral Animal Source Barrier |
| 18 Jul 2022 | K212509 | OSSIX Breeze | NPL Intraoral Animal Source Barrier |
| 18 Jul 2017 | K163714 | OSSIX BONE | NPM Animal Source Bone Grafting Material |
| 4 Aug 2016 | K160281 | OSSIX PLUS | NPL Intraoral Animal Source Barrier |
| 4 Aug 2016 | K153549 | OSSIX VOLUMAX | NPL Intraoral Animal Source Barrier |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (5), Bausch & Lomb Incorporated (3).
Sources
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 of the most recent filing, which can be a US agent.