Registered with FDA
Hudson Scientific LLC
Hudson, MI, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Hudson Scientific LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | OSSIX PLUSOSSIX VOLUMAX | 2018 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | OSSIX BONE | 2018 |
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
Hudson Scientific LLC 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: Datum Dental, Ltd. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jul 2017 | K163714 | OSSIX BONE | Datum Dental, Ltd. | NPM Animal Source Bone Grafting Material |
| 4 Aug 2016 | K160281 | OSSIX PLUS | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 4 Aug 2016 | K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HUDSON SCIENTIFIC LLCFDA reg. 3013037032 | Hudson, MI, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053280). 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.