# K963652: Pulpdent Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Oct 11, 1996 after 29 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) American Dental Products Wetting Agent and Desensitizer: named in the summary without a submission number
- (no number) Health-Dent Hema-Glu: named in the summary without a submission number
- (no number) Miles Inc. Gluma: named in the summary without a submission number

## Indications for use
Pulpdent DESENSITIZER is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.

Source page: https://510kreport.com/device/K963652
Methodology: https://510kreport.com/methodology