# K182219: SGS Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Sgs International, Ltd.
- Decided: Aug 29, 2019 after 379 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: 16 generations back to K960026 (1996). 261 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133362: SGS Dental Implant, Sgs International, Ltd. (2014) Summary page 4.

## Most influential descendants
- K182143: ALFA GATE Dental Implants System (2019), 0 descendants of its own

## Indications for use
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors. Two Stage Implants: P7N, P1D, P5D, P7D PEEK Temporary Abutments are not to exceed 30 days.

Source page: https://510kreport.com/device/K182219
Methodology: https://510kreport.com/methodology