Manufacturer registered with FDA
W.H. Holden Inc. DBA H & H Company
Hayden, ID, United States. Lists 35 dental device types with FDA across 1 registered establishment.
- Device types listed
- 35
- Brands and models
- 40
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What W.H. Holden Inc. DBA H & H Company currently lists, by FDA device type, with the brand and model names on the listing.
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
W.H. Holden Inc. DBA H & H Company 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: Osstell AB (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Aug 2019 | K181888 | Osstell Beacon | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| H & H CO.FDA reg. 2085199 | Hayden, ID, United States | Contract manufacturer, Manufacturer, Remanufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
H & H Co.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010035). 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.