# K073161: Replus Dental Implants (HA)

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Mar 7, 2008 after 119 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: 4 generations back to K894595 (1990). 14 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 1.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K029352: Nobel Biocare Tapered Groovy Implants. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K080713: Reactive Dental Implant System (2008), 23 descendants of its own
- K090234: Spectra System Dental Implants 2008 (2009), 22 descendants of its own
- K101225: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1 (2011), 18 descendants of its own
- K170392: S.I.N. Implant System (2017), 16 descendants of its own
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own

## Indications for use
The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

Source page: https://510kreport.com/device/K073161
Methodology: https://510kreport.com/methodology