# K172398: DENTCA DENTURE Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Nov 22, 2017 after 106 days
- Product code: PZY (Additively Manufactured, Preformed, Resin Denture Tooth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213343: Saremco Print CROWNTEC (2022), 6 descendants of its own
- K233596: VarseoSmile TriniQ (2023), 3 descendants of its own
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (2025), 1 descendant of its own
- K261356: Dura-Crown (2026), 0 descendants of its own
- K250497: Additive Manufacturing (Light Curing) Crown Bridge Resin (2025), 0 descendants of its own

## Indications for use
DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.

Source page: https://510kreport.com/device/K172398
Methodology: https://510kreport.com/methodology