# K133362: SGS Dental Implant

- Pathway: 510(k) (Abbreviated)
- Applicant: Sgs International, Ltd.
- Decided: Nov 21, 2014 after 385 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: 15 generations back to K960026 (1996). 260 ancestors in all.
2 later devices descend 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)
- K051719: A.B. Dental Devices, A.B. Dental Devices, Ltd. (2006) Summary page 5.
- K112440: AB Dental Devices Implants and Accessories, A.B. Dental Devices, Ltd. (2012) Summary page 5.
- K132125: A.B. Dental Devices Dental Implants System, A.B. Dental Devices, Ltd. (2014). Cleared while this submission was under review Summary page 5.
- K092555: Uno Narrow Implant, Mis Implants Technologies, Ltd. (2010) Summary page 5.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 5.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 5.
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 5.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 5.
- K073070: Dio Biotite-H Implant System, Dio Department Dsi, Inc. (2008) Summary page 5.

## Most influential descendants
- K182219: SGS Dental Implants System (2019), 1 descendant of its own
- 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. Two Stage Implants: P1, P7, P7N. One Stage: P7S, P9S. One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants. One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis. PEEK Temporary Abutments are for 30 days.

Source page: https://510kreport.com/device/K133362
Methodology: https://510kreport.com/methodology