# K030685: Teeth in an Hour - Ark Implant Concept

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 6, 2004 after 338 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: 1 generation back to K000018 (2000). 2 ancestors in all.
259 later devices descend from it; 2 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000018: Branemark Novum, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.

## Most influential descendants
- K050393: The Guided Surgery Concept (2005), 258 descendants of its own
- K053602: Procera Software, Model 33145 (2006), 248 descendants of its own
- K062493: Lava Software (2006), 242 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment (2009), 169 descendants of its own

## Recalls of this device
- Mar 14, 2019 · Class II · Z-1302-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during

## Indications for use
The Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fuffilled: * adequate amount of jaw bone * the quality of jaw bone must be judged as adequate * capability to open the mouth at least 50mm (this is especially important for lower jaws with teeth in the opposite jaw)

Source page: https://510kreport.com/device/K030685
Methodology: https://510kreport.com/methodology