# K131701: Z5MLB, Z5MLC - Pathway: 510(k) (Traditional) - Applicant: Z-Systems AG - Decided: Sep 5, 2013 after 86 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: 11 generations back to K960026 (1996). 100 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 102 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K120793: Z-LOOK3 Evo SLM, Z-Systems AG (2012) Summary page 2. - K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX, Z-Systems AG (2007) Summary page 2. - K093595: Ceraroot Implant System, Oral Iceberg S.L. (2011) Summary page 2. - K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 2. - K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2. - K050970: Milo Dental Implant System, Intra-Lock International (2005) Summary page 2. - K061319: Spectra System, Implant Direct, LLC (2006) Summary page 2. - K093518: Ace Surgical Secure Locator 3.25 Implant System, Ace Surgical Supply Co., Inc. (2010) Summary page 2. ## Most influential descendants - K200386: Z5-BL (2020), 0 descendants of its own ## Indications for use Zsmlb implants arc designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Zsmlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Zsmlc implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlc implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Source page: https://510kreport.com/device/K131701 Methodology: https://510kreport.com/methodology