# K052733: Almitech Inc. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Almitech, Inc.
- Decided: Dec 22, 2005 after 84 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 K861426 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894593: Bonefit Hollow Cylinder Implants, Institut Straumann AG (1990) Summary page 2.
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 2.
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 2.
- K920768: Hollow Screw Implants 6MM, 14MM, 16MM, The Straumann Co. (1992) Summary page 3.
- K010882: Blue Sky Bio Dental Implant System, Blue Sky Bio (2001) Summary page 2.
- K950578: Screw-Vent Implant, Core-Vent Corp. (1995) Summary page 2.
- K861426: Screw-Vent (TM) Implant/Endosseous Screw Implant, Core-Vent Corp. (1986) Summary page 2.

## Indications for use
The implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments

Source page: https://510kreport.com/device/K052733
Methodology: https://510kreport.com/methodology