# K100182: Salvin Dental Specialties Fixation Screw

- Pathway: 510(k) (Traditional)
- Applicant: Salvin Dental Specialties, Inc.
- Decided: May 10, 2010 after 109 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: 2 generations back to K952167 (1995). 3 ancestors in all.
2 later devices descend 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)
- K973180: Imtec Bone Tac, Imtec Corp. (1997) Summary page 1.

## Most influential descendants
- K151540: MC BIO Supertack Tack 3mm, 4mm and 5mm (2016), 1 descendant of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of contical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evdluated prior to use.

Source page: https://510kreport.com/device/K100182
Methodology: https://510kreport.com/methodology