# K231389: Harvest Dental HD Gum Strip

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Dental Products, LLC
- Decided: Aug 16, 2023 after 96 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033808 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033808: Gradia Gum, GC America, Inc. (2004) Summary page 4.

## Indications for use
Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).

Source page: https://510kreport.com/device/K231389
Methodology: https://510kreport.com/methodology