# K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jan 28, 2000 after 95 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). 9 ancestors in all.
942 later devices descend from it; 7 cite it directly.
0 of 952 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K023113: Replace Tiunite Endosseous Implant (2002), 689 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K050705: Tiunite Implants (2005), 532 descendants of its own
- K050258: Groovy Implants (2005), 511 descendants of its own
- K061003: SFB & CFB Implants (2006), 507 descendants of its own

## Indications for use
Nobel Biocare's Modified Surface Implant is 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 the single stage 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 predominarttly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Source page: https://510kreport.com/device/K993595
Methodology: https://510kreport.com/methodology