# K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jul 2, 2015 after 101 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, 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: 4 generations back to K970339 (1997). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor, W&H Dentalwerk Buermoos GmbH (2009) Summary page 4.
- K031204: Dentaport ZX, J. Morita USA, Inc. (2003) Summary page 4.
- K103653: E3 Torque Control Motor, Dentsply International, Inc. (2011) Summary page 4.
- K042822: TCM Endo V, Model 1534, Nouvag AG (2004) Summary page 4.
- K113674: Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare Handpiece Cleaner & Lubricant, Handpiece Headquarters, Inc. - Hpr, Inc. (2012) Summary page 4.

## Most influential descendants
- K163402: NLZ Motor System (2017), 1 descendant of its own
- K251701: Star E900 Electric System (2026), 0 descendants of its own

## Indications for use
The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

Source page: https://510kreport.com/device/K150750
Methodology: https://510kreport.com/methodology