# K071803: Ards Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Ards, Ltd.
- Decided: Sep 5, 2008 after 431 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: 10 generations back to K960026 (1996). 76 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 4.

## Most influential descendants
- K112795: Paltop Dental Implant System (2012), 11 descendants of its own
- K130462: Paltop Narrow Implant, Paltop Short Implant (2013), 8 descendants of its own
- K210117: Paltop Narrow Implant (2021), 5 descendants of its own
- K220200: Paltop Conical Implant System (2022), 2 descendants of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own

## Indications for use
ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.

Source page: https://510kreport.com/device/K071803
Methodology: https://510kreport.com/methodology