Impladent, Ltd.
Northborough, MA, US
IMPLADENT, LTD. appears in FDA device records in Northborough, MA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Impladent, Ltd. between 1980 and 2014. The busiest year on record is 1980, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 1 |
| 1984 | 1 |
| 1988 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | JEY | Substantially Equivalent | |
| K090794 | OSTEOTAPE | NPM | Substantially Equivalent | |
| K033098 | OSTEOGEN SBRG | LYC | Substantially Equivalent | |
| K982925 | LAMINOSS DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K933705 | LAMINOSS DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K923310 | OSTEOGEN (HA RESORB) | LYC | Substantially Equivalent | |
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | DZE | Substantially Equivalent for Some Indications | |
| K843398 | OSTEOGEN | LYC | Substantially Equivalent | |
| K812321 | HYDROXI-FLEX IMPLANT | DZE | Substantially Equivalent | |
| K792663 | FLEXI-CUP IMPLANT | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431866 | 2431866 | IMPLADENT, LTD. | 30 Bearfoot Rd, Northborough, MA 01532 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain