# K213599: SuperLine

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Feb 23, 2022 after 100 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: 12 generations back to K894595 (1990). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160965: SuperLine, Dentium Co., Ltd. (2017) Summary page 4.
- K123988: Anyonetm Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 4.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 4.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 4.

## Indications for use
SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

Source page: https://510kreport.com/device/K213599
Methodology: https://510kreport.com/methodology