# K991008: Dimension Bite

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Jun 18, 1999 after 84 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K812116 (1981). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954281: Panasil Impression Material, Roydent Dental Products, Inc. (1996) Summary page 1.
- K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive, Espe GmbH & Co. Kg. (1996) Summary page 1.
- K953374: Permadyne Garant 2:1, Espe GmbH & Co. Kg. (1995) Summary page 1.

## Most influential descendants
- K133400: Flash Bite (2014), 0 descendants of its own

## Indications for use
Bite registration Intraoral guide pin excursion tracing

Source page: https://510kreport.com/device/K991008
Methodology: https://510kreport.com/methodology