510(k) K082470 ยท KJJ Cleanser, Root Canal
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
| Applicant | Inter-Med, Inc., Racine WI, US |
| Decision | Substantially Equivalent, Apr 3, 2009 |
| Received | Aug 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 Terminated |
KJJ | None listed |
| Oct 1, 2019 | Inter-Med Llc Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 Terminated |
KJJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.