# K974202: Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Mar 19, 1998 after 129 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Ultradent UltraCid: named in the summary without a submission number
- (no number) Ultradent UltraCid F: named in the summary without a submission number
- (no number) Ultradent Concepsis: named in the summary without a submission number
- (no number) Dental Therapeutics AB Tubulicid Plus: named in the summary without a submission number
- (no number) Dental Therapeutics AB Tubulicid Blue Label: named in the summary without a submission number
- (no number) Dental Therapeutics AB Tubulicid Red Label: named in the summary without a submission number

## Most influential descendants
- K033938: Clearfil Protect Bond (2004), 4 descendants of its own
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own

## Indications for use
Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.

Source page: https://510kreport.com/device/K974202
Methodology: https://510kreport.com/methodology