# K073142: Nobelreplace Hexagonal Implant

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare USA, LLC
- Decided: Jan 11, 2008 after 65 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894595 (1990). 22 ancestors in all.
95 later devices descend from it; 4 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062566: Nobelreplace Tapered Conical Connection, Nobel Biocare USA, LLC (2006) Summary page 1.

## Most influential descendants
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## Recalls of this device
- Dec 17, 2021 · Class II · Z-0658-2022: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result
- Jul 20, 2020 · Class II · Z-2828-2020: Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second sur

## Indications for use
Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Source page: https://510kreport.com/device/K073142
Methodology: https://510kreport.com/methodology