# K991114: Regular Diameter Single Stage (RDS) TPS Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Jul 14, 1999 after 104 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 K894595 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite 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.
- K924589: Restore Self Tapping Dental Implant System, Implant Support Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K994205: Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant System (2000), 1 descendant of its own
- K053643: Stage- 1 Temporary/Healing Cap, Model 42021-42026 (2006), 0 descendants of its own

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

Source page: https://510kreport.com/device/K991114
Methodology: https://510kreport.com/methodology