# K992937: Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Feb 29, 2000 after 182 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894595 (1990). 9 ancestors in all.
735 later devices descend from it; 7 cite it directly.
0 of 745 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 3.
- K930071: Sargon Cylindro-Blade Implant, Sargon Ent., Inc. (1994) Summary page 3.

## Most influential descendants
- K013067: Frialoc Dental Implant System (2002), 568 descendants of its own
- K021318: Xive Dental Implant System (2002), 547 descendants of its own
- K032158: Xive Dental Implant System Multiple (2003), 542 descendants of its own
- K024004: Xive Transgingival Dental Implant System (2003), 425 descendants of its own
- K032284: Xive TG Dental Implant System (2003), 394 descendants of its own

## Recalls of this device
- Jul 18, 2016 · Class II · Z-2314-2016: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

## Indications for use
Selected Branemark System® implant products (those identified in the preceding section, “Device Name”) are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient’s chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. If a single stage surgical procedure is used, these implants may be loaded immediately following insertion - PROVIDED — at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage most often be obtained.

Source page: https://510kreport.com/device/K992937
Methodology: https://510kreport.com/methodology