# K990511: X-Tip Intraosseous Perforator

- Pathway: 510(k) (Traditional)
- Applicant: Schiff & Co.
- Decided: Apr 27, 1999 after 68 days
- Product code: DZM (Needle, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4730
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.

Source page: https://510kreport.com/device/K990511
Methodology: https://510kreport.com/methodology