# K061395: Calset Composite Heater

- Pathway: 510(k) (Traditional)
- Applicant: Addent, Inc.
- Decided: Jun 23, 2006 after 35 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aesthetic Warmer: named in the summary without a submission number

## Most influential descendants
- K182017: Compex HD (2019), 0 descendants of its own

## Indications for use
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to 130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).

Source page: https://510kreport.com/device/K061395
Methodology: https://510kreport.com/methodology