# K191103: Parkell Desensitizer Gel

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Nov 22, 2019 after 211 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910424 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131068: Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid, Kuraray Noritake Dental, Inc. (2013) Summary page 4.

## Indications for use
Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments: treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion; treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; treatment of tooth hypersensitivity associated with bleaching; and treatment of prepared dentin for fillings and/or prosthetic restorations.

Source page: https://510kreport.com/device/K191103
Methodology: https://510kreport.com/methodology