# K983477: Super Seal

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Dental, Inc.
- Decided: Dec 22, 1998 after 81 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
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033521: Bisblock (2004), 4 descendants of its own
- K082594: Remesense (2009), 3 descendants of its own
- K122421: Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid (2012), 2 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K131068: Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid (2013), 1 descendant of its own

## Indications for use
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.

Source page: https://510kreport.com/device/K983477
Methodology: https://510kreport.com/methodology