# K962442: Hytac Aplitip/Hytac Osb

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Sep 11, 1996 after 79 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 K900510 (1990). 3 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900510: Pertac-Hybrid, Espe GmbH (Us) (1990) Summary page 1.
- K951836: Compolglass Compoglass Sca, Ivoclar North America, Inc. (1995) Summary page 1.
- K904289: Pertac Universal Bond, Espe GmbH (Us) (1990) Summary page 1.

## Most influential descendants
- K984246: Prompt L-Pop (1999), 5 descendants of its own
- K992966: Reference (1999), 1 descendant of its own
- K210945: Ultra SEP (2021), 0 descendants of its own
- K071688: Reliance S.E.P. (2007), 0 descendants of its own
- K993566: Promptflow (1999), 0 descendants of its own

## Indications for use
Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.

Source page: https://510kreport.com/device/K962442
Methodology: https://510kreport.com/methodology