# K993560: Frialit-2 Bone Profiler

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Jan 10, 2000 after 81 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 K960417 (1996). 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)
- K960417: 3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments, Implant Innovations, Inc. (1996) Summary page 1.

## Indications for use
The FRIALIT-2® Bone Profiler in intended to be used for the removal of bone that has grown over the top of the implant during the integration period.

Source page: https://510kreport.com/device/K993560
Methodology: https://510kreport.com/methodology