# K874189: Dual-Cure Radiopaque

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Corp.
- Decided: Feb 11, 1988 after 120 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 5 (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
- Mar 31, 2011 · Not classified · Z-0156-2012: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even aft
- Mar 31, 2011 · Not classified · Z-0155-2012: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even aft
- Mar 31, 2011 · Not classified · Z-0153-2012: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even aft
- Mar 31, 2011 · Not classified · Z-0157-2012: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even aft
- Mar 31, 2011 · Not classified · Z-0154-2012: Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even aft

Source page: https://510kreport.com/device/K874189
Methodology: https://510kreport.com/methodology