Manufacturer registered with FDA
Impladent , Ltd.
Northborough, MA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 101980–2014
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Impladent , 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 | Manufacturer | Impladent , Ltd. | 10 clearances | 1980–2014 | Below |
| Israel | AMAR | Manufacturer | Impladent Ltd | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | IMPLADENT LTD | 1 | 2017–2017 | 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 Impladent , Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | TriStar Bone Graft Fixation System | 2015 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | TriStar Bone Graft Fixation System | 2015 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | OsteoGen | 2007 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | OsteoTape / OsteoGen Plug / OsteoGen Strip | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Impladent , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Dec 2014 | K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | JEY Bone Plate |
| 10 Dec 2009 | K090794 | OSTEOTAPE | NPM Animal Source Bone Grafting Material |
| 27 Apr 2004 | K033098 | OSTEOGEN SBRG | LYC Synthetic Bone Grafting Material |
| 18 May 1999 | K982925 | LAMINOSS DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 24 Jun 1996 | K933705 | LAMINOSS DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 31 May 1995 | K923310 | OSTEOGEN (HA RESORB) | LYC Synthetic Bone Grafting Material |
| 1 Sep 1988 | K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | DZE Root-Form Endosseous Implant |
| 27 Dec 1984 | K843398 | OSTEOGEN | LYC Synthetic Bone Grafting Material |
| 29 Oct 1981 | K812321 | HYDROXI-FLEX IMPLANT | DZE Root-Form Endosseous Implant |
| 9 Jan 1980 | K792663 | FLEXI-CUP IMPLANT | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Suncoast Dental Corp. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IMPLADENT, LTD.FDA reg. 2431866 | Northborough, MA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2431866). 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.