# K994205: Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Feb 29, 2000 after 90 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: 2 generations back to K894595 (1990). 4 ancestors in all.
1 later device descends 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)
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K920768: Hollow Screw Implants 6MM, 14MM, 16MM, The Straumann Co. (1992) Summary page 1.
- K991114: Regular Diameter Single Stage (RDS) TPS Dental Implant System, Lifecore Biomedical, Inc. (1999) Summary page 1.

## Most influential descendants
- K053643: Stage- 1 Temporary/Healing Cap, Model 42021-42026 (2006), 0 descendants of its own

## Indications for use
The Stage-1™ Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous maxillary and mandibular arches in areas with sufficient alveolar bone width and height to surround the submerged portion of the implant with at least 1mm of bone, both buccally and lingually.

Source page: https://510kreport.com/device/K994205
Methodology: https://510kreport.com/methodology