# K983120: Bicortical Screw

- Pathway: 510(k) (Traditional)
- Applicant: Oraltronics Marketing-Und Vertriebs GmbH
- Decided: Jul 29, 1999 after 328 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 K820013 (1982). 6 ancestors in all.
94 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 6.
- K820013: Titanium Implant Devices, Bofors Nobelpharma, Inc. (1982) Summary page 6.
- K841551: Osseointegrated Fixtures-Tissue Integr, Bofors Nobelpharma, Inc. (1984) Summary page 6.
- K925764: Branemark System 4.00 MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 6.
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 6.
- K934825: Branemark System, Nobelpharma USA, Inc. (1994) Summary page 6.
- (no number) Park Dental Research Corp. Pin Implant: named in the summary without a submission number

## Most influential descendants
- K053242: Pitt-Easy Dental Implant System (2006), 86 descendants of its own
- K083297: Pitt-Easy Dental Implant System (2009), 84 descendants of its own
- K102804: Spi Titanium Base for Cad/Cam (2011), 83 descendants of its own
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own

## Indications for use
The Bicortical Screw is intended for surgical placement in edentulous anterior regions of the maxillary and/or mandibular arch to support crowns, bridges, or overdentures. In many cases the Bicortical Screw is inserted immediately after extraction.

Source page: https://510kreport.com/device/K983120
Methodology: https://510kreport.com/methodology