# K033521: Bisblock

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jan 16, 2004 after 70 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- 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 K983477 (1998). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983477: Super Seal, Phoenix Dental, Inc. (1998) Summary page 1.

## Most influential descendants
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K132426: Sylphar Remesense Sensitivity Relief Strips (2014), 0 descendants of its own
- K123653: Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized) (2013), 0 descendants of its own

## Indications for use
BisBlock forms oxalate crystals which occlude the dentin tubules resulting in a reduction of sensitivity of teeth by applying: 1. Prior to temporization (placement of provisional restorations). 2. Prior to permanent cementation of indirect restorations. 3. Prior to placement of direct restorations. 4. When root surfaces are exposed.

Source page: https://510kreport.com/device/K033521
Methodology: https://510kreport.com/methodology