# K123653: Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jun 3, 2013 after 188 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K030922 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033521: Bisblock, Bisco, Inc. (2004) Summary page 1.
- K983477: Super Seal, Phoenix Dental, Inc. (1998) Summary page 1.
- K120109: Super Seal Tooth Desensitizer, Phoenix Dental, Inc. (2012) Summary page 1.

## Indications for use
The indication for use of Seal Block PRO is to relieve sensitive teeth. Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by: Hot Cold Sweet Acidic Dental whitening agents Seal Block PRO can also be used to relieve sensitivity: Prior to temporization (placement of provisional restorations). Prior to permanent cementation of indirect restorations. Prior to placement of direct restorations. When root surfaces are exposed. Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents

Source page: https://510kreport.com/device/K123653
Methodology: https://510kreport.com/methodology