# K182017: Compex HD

- Pathway: 510(k) (Traditional)
- Applicant: Addent, Inc.
- Decided: Apr 29, 2019 after 276 days
- Product code: QGO (Composite Resin Warmer)
- Device class: 1
- Regulation: 21 CFR 872.6100
- 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 K061395 (2006). 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)
- K061395: Calset Composite Heater, Addent, Inc. (2006) Summary page 4.

## Indications for use
The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).

Source page: https://510kreport.com/device/K182017
Methodology: https://510kreport.com/methodology