# K971350: Series XE, Series SE, Series TE

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Mega Societe Anonyme
- Decided: Jun 4, 1997 after 55 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
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices 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.

## Most influential descendants
- K040674: Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles (2004), 26 descendants of its own
- K092412: Strong Implant Handpieces (2009), 15 descendants of its own
- K111616: E-CUBE (2011), 10 descendants of its own
- K133298: Endo Smart (2014), 6 descendants of its own
- K153285: EMS-200 (2016), 5 descendants of its own

## Indications for use
These contra-angles are intended for use on dental motors equipped with a-coupling according to ISO-Standard 3964. The speed of the motors may not exceed 40 000 RPM. These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as determined in ISO Standard 1797. They allow to carry out all low speed dental works Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.

Source page: https://510kreport.com/device/K971350
Methodology: https://510kreport.com/methodology