Manufacturer registered with FDA
Highridge Medical, LLC
Westminster, CO, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9138 registrations outside the US
- Establishments
- 2United States
Registered in 9 markets
Where regulators' registries name Highridge Medical, LLC 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 | Highridge Medical, LLC | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Highridge Medical LLC | 57 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HIGHRIDGE MEDICAL, LLC | 47 | 2010–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Highridge Medical, LLC | 13 | 2005–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Highridge Medical, LLC. | 11 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HIGHRIDGE MEDICAL LLC | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HIGHRIDGE MEDICAL, LLC. | 3 | 2017–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HIGHRIDGE MEDICAL,LLC | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Highridge Medical, LLC | 1 | 2026–2026 | 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 Highridge Medical, 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 |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | — | 2014 |
| Intraosseous Fixation WireDZK · Class 2 | — | Maker | — | 2016 |
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
Highridge Medical, 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: Interpore Intl. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Mar 1995 | K950165 | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS | Interpore Intl. | LYC Synthetic Bone Grafting Material |
| 23 May 1986 | K860983 | INTERPORE 200 POROUS HYDROXYAPATITE | Interpore Intl. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Highridge Medical, LLCFDA reg. 3012447612 | Westminster, CO, United States | Specification developer |
| Olive Branch Distribution CenterFDA reg. 3016050940 | Olive Branch, MS, United States | Contract manufacturer |
Other names on FDA records
Olive Branch Distribution Center
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9061535). 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.