# K962440: Pertac II/Pertac II Aplitip

- 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). 1 ancestor in all.
90 later devices descend from it; 5 cite it directly.
0 of 92 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.

## Most influential descendants
- K974458: Compolute Aplicap (1998), 70 descendants of its own
- K020256: Unicem (2002), 63 descendants of its own
- K992645: Sinfony (1999), 59 descendants of its own
- K043043: Hermes Bond 2 (2005), 37 descendants of its own
- K071131: UNO (2007), 35 descendants of its own

## Indications for use
The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.

Source page: https://510kreport.com/device/K962440
Methodology: https://510kreport.com/methodology