Ab Ardent
Tonawanda, NY, US
Ab Ardent appears in FDA device records in Tonawanda, NY. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Ab Ardent between 1998 and 2013. The busiest year on record is 2002, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 3 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 6 |
| 2004 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131753 | MERIDIAN | EBF | Substantially Equivalent | |
| K040465 | LATIT FLOW | EBF | Substantially Equivalent | |
| K022971 | MICROHYBRID 11 | EBF | Substantially Equivalent | |
| K022975 | ETCHING 15 | EBF | Substantially Equivalent | |
| K022974 | MICROHYBRID 12 | EBF | Substantially Equivalent | |
| K022973 | ADHESIVE 14 | KLE | Substantially Equivalent | |
| K022972 | MICROFILL 13 | EBF | Substantially Equivalent | |
| K020452 | HIGH SILVER CONVENTIONAL | EJJ | Substantially Equivalent | |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | EJJ | Substantially Equivalent | |
| K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | EMA | Substantially Equivalent | |
| K982460 | VIVACAP HR | EJJ | Substantially Equivalent | |
| K982458 | VIVALLOY HR | EJJ | Substantially Equivalent | |
| K982456 | AMALCAP PLUS | EJJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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