# K172176: Parkell Universal Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Nov 21, 2017 after 125 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K900510 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.

## Indications for use
1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers). 2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia). 3. Desensitization of dentin. 4. Sealing of dentin, cementum or enamel.

Source page: https://510kreport.com/device/K172176
Methodology: https://510kreport.com/methodology