# K182143: ALFA GATE Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Gate Mazen, Ltd.
- Decided: Oct 3, 2019 after 422 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). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182219: SGS Dental Implants System, Sgs International, Ltd. (2019). Cleared while this submission was under review Summary page 4.

## Indications for use
ALFA GATE® 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. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.0Ømm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants. ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.

Source page: https://510kreport.com/device/K182143
Methodology: https://510kreport.com/methodology