# K160213: s-Clean Tapered II RBM Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Jun 21, 2016 after 144 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: 10 generations back to K944964 (1995). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150344: Dentis Dental Implant System, Dentis Co., Ltd. (2015) Summary page 5.
- K073486: Dentis Dental Implant System, Dentis Co., Ltd. (2008). Our reading of the summary gave K074386, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped that is an earlier device of this one’s maker, Dentis Co., Ltd., in this field. Summary page 5.

## Indications for use
The s-Clean Tapered I RBM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted Interforaminal placed implants.

Source page: https://510kreport.com/device/K160213
Methodology: https://510kreport.com/methodology