# K031851: Dentiseptic HPC

- Pathway: 510(k) (Traditional)
- Applicant: Bethel, Inc.
- Decided: Aug 1, 2003 after 46 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: 2 generations back to K900093 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963664: Dental Handpiece and Accessory, Filmtech, Inc. (1996) Summary page 2.
- K900093: Disposa-Shield (TM) Infection Control Barrier, Dentsply Intl. (1990) Summary page 2.

## Indications for use
The Dentaseptic HPC device is intended as a single use, disposable, transparent, plastic, disposable, non-sterile protective cover to be placed over various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover acts as a physical barrier that assists in providing surface protection for the handpieces, reducing cross contamination of equipment, augmenting existing infection control techniques and making clean up and disinfection less time consuming.

Source page: https://510kreport.com/device/K031851
Methodology: https://510kreport.com/methodology