# K103089: Seven Implants; Biocom Implants; Lance Implants

- Pathway: 510(k) (Traditional)
- Applicant: Mis - Implant Technologies, Ltd.
- Decided: Sep 15, 2011 after 331 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: 1 generation back to K063779 (2007). 1 ancestor in all.
49 later devices descend from it; 8 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063779: Osseospeed 4.0S-6MM, Model 24619, Astra Tech, Inc. (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K042637: The 5.0 X 6.0MM Dental Implant, Bicon, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K180282: MIS Internal Hex Dental Implant System (2018), 11 descendants of its own
- K172225: Atlantis Abutment for MIS Implant (2017), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own

## Indications for use
MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. MIS short implants are to be used only with straight abutments.

Source page: https://510kreport.com/device/K103089
Methodology: https://510kreport.com/methodology