# K192839: DSP Implant System

- Pathway: 510(k) (Traditional)
- Applicant: D.S.P Industrial Eireli
- Decided: Feb 11, 2021 after 504 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: 17 generations back to K960026 (1996). 400 ancestors in all.
No later device cites it as a predicate yet.
0 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101207: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2010) Summary page 4.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 4.
- K083561: Neoss Proactive Implant, Neoss, Ltd. (2009) Summary page 4.
- K925762: Branemark System Self-Tapping Fixture, Nobelpharma USA, Inc. (1993) Summary page 4.
- K150669: Neoss TiBase, Neoss CoCr Abutments (Mono and Multi), Neoss, Ltd. (2015) Summary page 4.
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 4.
- K170398: S.I.N. Dental Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.
- K183024: Implacil Implant System, Implacil DE Bortoli Material Odontologico Ltda (2020). Cleared while this submission was under review Summary page 4.
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 22.
- K062931: Implus Implant System, Leader Italia S.R.L. (2007) Summary page 22.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 4.

## Indications for use
The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K192839
Methodology: https://510kreport.com/methodology