SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA— 510(k) K082470
Substantially EquivalentInter-Med, Inc.
FDA 510(k) clearance K082470 for SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA, Substantially Equivalent on 2009-04-03. Applicant: Inter-Med, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Inter-Med, Inc.
- Product code
- Code KJJ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
Recent devices under product code KJJ
view allMore clearances from Inter-Med, Inc.
view allRecalls naming K082470
K-number listed on FDA's recall record- Z-0011-2020 — 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
- Z-0012-2020 — Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
- Z-0013-2020 — Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
- Z-0014-2020 — Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
- Z-0015-2020 — Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
- Z-0016-2020 — Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
- Z-0017-2020 — Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082470.
Data sourced from openFDA. This site is unofficial and independent of the FDA.