# K962743: Pulpdent Sodium Hypochlorite Solution

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Aug 6, 1996 after 22 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Premier Hypogen: named in the summary without a submission number
- (no number) Union Broach Sodium Hypochlorite Solution: named in the summary without a submission number

## Most influential descendants
- K061689: Aquatine EC Endodontic Cleanser (2006), 11 descendants of its own
- K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra (2009), 6 descendants of its own
- K070401: Endo-CHX (2007), 2 descendants of its own
- K193357: V-Mix (2020), 1 descendant of its own
- K112250: CHX=CHX Plus (2011), 1 descendant of its own

## Indications for use
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hypochlorite in water.

Source page: https://510kreport.com/device/K962743
Methodology: https://510kreport.com/methodology