# K954758: Rootform Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Swiss Dental Center
- Decided: Aug 18, 1997 after 672 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 K912262 (1991). 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)
- K912262: Hexlock, Imtec Corp. (1991) Summary page 2.
- K926101: Phoenix Opti-Max Dent Impl W/Plas-Spray Tita/Hydro, Phoenix Dental, Inc. (1994) Summary page 2.
- K926102: Phoenix Opti-Max Dent Implant W/Plasma-Spray Titan, Phoenix Dental, Inc. (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- K921966: Steri-Oss HA and TPS Coated Cylindrical Implants. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abutment and prosthetic devices-including artificial teeth; bridges,anddentures.

Source page: https://510kreport.com/device/K954758
Methodology: https://510kreport.com/methodology