# K082591: Flexitime Bite

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc., Dental Products Division
- Decided: Dec 5, 2008 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Flexitime Bite is an addition-cross-linking polyvinyl siloxane with a very high final Shore D hardness of 40. Its surface properties and optimized color enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.

Source page: https://510kreport.com/device/K082591
Methodology: https://510kreport.com/methodology