Incisive Technologies Pty Ltd
Ferntree Gully Victoria, AU
Incisive Technologies Pty Ltd appears in FDA device records in Ferntree Gully Victoria, AU. FDA records list 4 510(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 4 510(k) clearances for Incisive Technologies Pty Ltd between 1994 and 2023. The busiest year on record is 1994, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222560 | BlueCheck™ Caries Detection & Monitoring | LFC | Substantially Equivalent | |
| K945143 | DENTAL LASER FIBER SYSTEM | GEX | Substantially Equivalent | |
| K943693 | PULSEMASTER S SERIES | GEX | Substantially Equivalent | |
| K942217 | PULSEJET DENTAL LASER SYSTEM | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3033588343 | 3033588343 | Incisive Technologies Pty Ltd | 5 William Street, Ferntree Gully Victoria 3156 AU | 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