# K961381: Kis-Iii Non-Submerged Implant, Screws and Cylinders

- Pathway: 510(k) (Traditional)
- Applicant: The Emerging Technologies Group
- Decided: Sep 9, 1997 after 539 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 K902435 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902433: Dia Anatomic Abutment, Dental Imaging Assoc., Inc. (1992) Summary page 1.
- K902434: Dia Healing Cap, Dental Imaging Assoc., Inc. (1991) Summary page 1.
- K902435: Dia Impression Coping, Dental Imaging Assoc., Inc. (1991) Summary page 1.
- K932123: Implant Innovation Pre-Angled Abutment System, Implant Innovations International, Inc. (1994) Summary page 1.
- K925766: Branemark System Temporary Solutions, Nobelpharma USA, Inc. (1994) Summary page 1.
- K933462: Conical Abutment, Implant Innovations, Inc. (1994) Summary page 1.

## Indications for use
The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic 1load is incorporated into the implant sites.

Source page: https://510kreport.com/device/K961381
Methodology: https://510kreport.com/methodology