# K992966: Reference

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Oct 7, 1999 after 35 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: 4 generations back to K900510 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962440: Pertac II/Pertac II Aplitip, Espe GmbH & Co. Kg. (1996) Summary page 1.
- K984246: Prompt L-Pop, Espe Dental AG (1999) Summary page 1.
- K962442: Hytac Aplitip/Hytac Osb, Espe GmbH & Co. Kg. (1996) Summary page 1.
- K960954: Ketac-Molar Aplicap, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Most influential descendants
- K993566: Promptflow (1999), 0 descendants of its own

## Indications for use
Composite restorative material for: Restorations of type I, II; III, IV, and V cavities (according to Black) Fillings in deciduous teeth Extended fissure sealing Cervical erosions and abrasions Cutting edge build-up Repairing of veneers made of composite and ceramics Inlays fabrication Interlocking of loose teeth

Source page: https://510kreport.com/device/K992966
Methodology: https://510kreport.com/methodology