# K101545: Genesis Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Keystone Dental
- Decided: Oct 28, 2010 after 147 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960026 (1996). 122 ancestors in all.
15 later devices descend from it; 7 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 1.
- K053088: Slactive Implants, Institut Straumann AG (2006) Summary page 1.
- K061176: Straumann Dental Implants, Institut Straumann AG (2006) Summary page 1.
- K062432: Nanotite Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.

## Most influential descendants
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own
- K213449: DS Implants abutments provided with the EV connection (2021), 2 descendants of its own
- K123512: Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM (2013), 2 descendants of its own
- K123415: Biodenta Dental Implant System- Bone Level Tapered (2013), 2 descendants of its own

## Recalls of this device
- Mar 13, 2018 · Class II · Z-1485-2018: The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
- Jul 5, 2011 · Class II · Z-0923-2013: Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
- Jul 5, 2011 · Class II · Z-0924-2013: Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment

## Indications for use
The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or hilly edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing fuinction and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

Source page: https://510kreport.com/device/K101545
Methodology: https://510kreport.com/methodology