# K151540: MC BIO Supertack Tack 3mm, 4mm and 5mm

- Pathway: 510(k) (Traditional)
- Applicant: Eli-Ka Technologies
- Decided: May 26, 2016 after 353 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952167 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100182: Salvin Dental Specialties Fixation Screw, Salvin Dental Specialties, Inc. (2010) Summary page 4.

## Most influential descendants
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

Source page: https://510kreport.com/device/K151540
Methodology: https://510kreport.com/methodology