# K072754: Axenic DHP Disposable High-Performance Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Axenic Dental, Inc.
- Decided: Jan 25, 2008 after 120 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K923469 (1992). 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)
- K923469: Oralsafe, Oralsafe, Inc. (1992) Summary page 1.

## Indications for use
The Axenic Dental, Inc. DHPTM "Disposable High-Performance" sterile, pyrogen free, maintenance free handpiece, with appropriate burs, is indicated for all dental practice procedures for which metal handpieces are used, including cutting, shaping and preparing teeth for cavity repair, crowns and bridges. The device is suitable for use in circumstances where infectious, inter-patient contamination is a concern. The device can be used for duration of 12 to 14 minutes cutting time during single patient use.

Source page: https://510kreport.com/device/K072754
Methodology: https://510kreport.com/methodology