Data / Medical devices / United States / Impladent, Ltd.
Impladent, Ltd.: FDA-registered device maker in Northborough, MA, United States, 4 510(k) clearances
Impladent, Ltd. is registered with the FDA (registration 2431866) in Northborough, MA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 18, 2014. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2431866
- Address
- 30 Bearfoot Rd, Northborough, MA, United States, 01532
- Owner or operator
- IMPLADENT, LTD. (2431866)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 28, 2007
- Registered through
- 2026
- Brand names listed
- CollaForm / OsteoMend XTD, OsteoGen, OsteoTape / OsteoGen Plug / OsteoGen Strip, TriStar Bone Graft Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | 2 | Specification developer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2014 | K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | JEY | Substantially Equivalent | Impladent , Ltd. | accessdata.fda.gov |
| February 2, 2011 | K100927 | SURGIAID | KGN | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
| December 10, 2009 | K090794 | OSTEOTAPE | NPM | Substantially Equivalent | Impladent , Ltd. | accessdata.fda.gov |
| April 27, 2004 | K033098 | OSTEOGEN SBRG | LYC | Substantially Equivalent | Impladent , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Bone
- All makers of Screw, Fixation, Intraosseous
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Bone Grafting Material, Animal Source
- All makers of Bone Grafting Material, Synthetic
Updated December 18, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.