# K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med, Inc.
- Decided: Apr 3, 2009 after 219 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003422 (2001). 6 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962743: Pulpdent Sodium Hypochlorite Solution, Pulpdent Corp. (1996) Summary page 1.
- K061689: Aquatine EC Endodontic Cleanser, Puricore, Inc. (2006) Summary page 1.
- (no number) ChlorCid Sodium Hypochlorite Solution: named in the summary without a submission number

## Most influential descendants
- K193357: V-Mix (2020), 1 descendant of its own
- K211813: Triton (2021), 0 descendants of its own
- K173163: ChlorCid, ChlorCid V, ChlorCid Surf (2018), 0 descendants of its own
- K151852: PacEndo Sodium Hyprochlorite (2015), 0 descendants of its own
- K141352: Endocyn Root Canal Irrigation Solution (2014), 0 descendants of its own

## Recalls of this device
- Jun 27, 2019 · Class II · Z-0011-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0012-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0015-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0016-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0017-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0013-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so
- Jun 27, 2019 · Class II · Z-0014-2020: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained so

## Indications for use
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM solutions used for the debridement and in the instrumentation of root canal. Sodium Hypochlorite 3% & 6% and Chlor-XTRATM 6 % are Sodium Hypochiorite solutions in water.

Source page: https://510kreport.com/device/K082470
Methodology: https://510kreport.com/methodology