# K993095: Frialit-2 Select Components

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Dec 9, 1999 after 84 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K950204 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950204: 3I Standard Threaded/Self-Tapping Threaded Implants, Miniplants (TM), Implant Innovations, Inc. (1995) Summary page 1.

## Indications for use
The Select Components of the FRIALIT-2® Dental Implant System are indicated for use in the determination of implant placement, implant angle and to measure the available soft tissue height. The Select Components can also be used in determining the potential abutment angle and soft tissue height.

Source page: https://510kreport.com/device/K993095
Methodology: https://510kreport.com/methodology