# K961387: MT-X

- Pathway: 510(k) (Traditional)
- Applicant: The Emerging Technologies Group
- Decided: Sep 25, 1996 after 190 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K902435 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902433: Dia Anatomic Abutment, Dental Imaging Assoc., Inc. (1992) Summary page 1.
- K902434: Dia Healing Cap, Dental Imaging Assoc., Inc. (1991) Summary page 1.
- K902435: Dia Impression Coping, Dental Imaging Assoc., Inc. (1991) Summary page 1.
- K932123: Implant Innovation Pre-Angled Abutment System, Implant Innovations International, Inc. (1994) Summary page 1.
- K925766: Branemark System Temporary Solutions, Nobelpharma USA, Inc. (1994) Summary page 1.
- K934826: Branemark-Healing Caps, DCC045, DCC046, DCC104, Nobelpharma USA, Inc. (1994) Summary page 1.
- K934495: Branemark System (R) Ucla-Type Abutment Complete, Nobelpharma AB (1994) Summary page 1.
- K933969: Tapered Abutment and Related Components, Implant Innovations, Inc. (1994) Summary page 1.
- K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments, Implant Innovations, Inc. (1994) Summary page 1.
- K933462: Conical Abutment, Implant Innovations, Inc. (1994) Summary page 1.

## Indications for use
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

Source page: https://510kreport.com/device/K961387
Methodology: https://510kreport.com/methodology