# K102526: BLO2X Oxygen Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Co., Inc.
- Decided: Oct 22, 2010 after 50 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K941065 (1994). 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)
- K941065: Deox, Oxygen Barrier Viscous Solution, Ultradent Products, Inc. (1994) Summary page 2.

## Indications for use
BLO 2 X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or Juting to prevent the oxygen inhibition layer from forming. BLO 2 X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.

Source page: https://510kreport.com/device/K102526
Methodology: https://510kreport.com/methodology