# K163060: Deep Conical (DC) Implants and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Jun 13, 2017 after 224 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: 12 generations back to K894595 (1990). 186 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.
- K052490: Endosseous Dental Implant System, Northern Implants, LLC (2005) Summary page 4.
- K070905: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 4.
- K142211: OT Equator, Rhein'83 Srl (2015) Summary page 4.
- K053478: Endosseous Dental Implant System, Northern Implants, LLC (2006) Summary page 4.
- K070841: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 4.

## Most influential descendants
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 descendants of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own
- K222457: Provata Implant System (2023), 0 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own

## Indications for use
Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: » replacing single and multiple missing teeth in the mandible and maxilla, « immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, + immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

Source page: https://510kreport.com/device/K163060
Methodology: https://510kreport.com/methodology