# K171728: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold Dental, LLC
- Decided: Sep 28, 2017 after 108 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). 91 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153099: Inclusive Tapered Implant System, Prismatik Dentalcraft, Inc. (2016) Summary page 4.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 4.
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 4.

## Most influential descendants
- K213576: Tatum Surgical Dental Implant System (2022), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## Indications for use
The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary. The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

Source page: https://510kreport.com/device/K171728
Methodology: https://510kreport.com/methodology