# K960112: KIS MT5

- Pathway: 510(k) (Traditional)
- Applicant: The Implant Center of the Palm Beaches
- Decided: Mar 15, 1996 after 64 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 s ar to those of other implant systems in their intended use whi is to facilitate the prosthetic phase and installation of the ros esi“m"e302 for the patient.

Source page: https://510kreport.com/device/K960112
Methodology: https://510kreport.com/methodology