# K103084: Neodent Graft Screw

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: Feb 14, 2011 after 118 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: 6 generations back to K761228 (1976). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073342: Salvin Dental Specialties, Inc., Fixation Screw, Salvin Dental Specialties, Inc. (2008) Summary page 2.
- K080430: Stoma Bone Block Screw, Storz AM Mark GmbH (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K000515: Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,, Interpore Cross Intl. (2000). Our reading of the summary gave K000515, FDA’s number for Pro Osteon 200R Resorbable Bone Graft Substitute, Models… (Interpore Cross Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bone Block Fixation Set”. Kept off the family tree.

## Indications for use
This product is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Source page: https://510kreport.com/device/K103084
Methodology: https://510kreport.com/methodology