# K073342: Salvin Dental Specialties, Inc., Fixation Screw

- Pathway: 510(k) (Traditional)
- Applicant: Salvin Dental Specialties, Inc.
- Decided: Mar 26, 2008 after 119 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: 5 generations back to K761228 (1976). 18 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023260: 1.2MM Osteomed Auto-Drive Screw System, Osteomed Corp. (2002) Summary page 1.
- K970912: Leibinger Self-Drilling Screw, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K050492: Integra Bone Fixation System, Integra Lifesciences Corp. (2005) Summary page 1.
- K040860: Integra Bone Fixation System, Integra LifeSciences Corporation (2004) Summary page 1.

## Most influential descendants
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own
- K103084: Neodent Graft Screw (2011), 0 descendants of its own

## Indications for use
The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only

Source page: https://510kreport.com/device/K073342
Methodology: https://510kreport.com/methodology