# K884588: Heliomolar (R) Dental Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Williams Dental Co., Inc.
- Decided: Jan 27, 1989 after 86 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 3, 2017 · Class III · Z-0665-2018: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
- Aug 3, 2017 · Class III · Z-0667-2018: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
- Aug 3, 2017 · Class III · Z-0668-2018: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
- Aug 3, 2017 · Class III · Z-0666-2018: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Source page: https://510kreport.com/device/K884588
Methodology: https://510kreport.com/methodology