# K061224: Lapdoc I

- Pathway: 510(k) (Traditional)
- Applicant: Robodent GmbH
- Decided: Sep 5, 2006 after 127 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K983831 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023424: Igi-System, Denx Advanced Dental Systems (2003) Summary page 1.
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 1.
- K023651: Vectorvision Cranial/Ent, Brainlab AG (2004) Summary page 1.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 1.

## Indications for use
The Lapdoc navigation system is a computerized navigational system intended to provide assistance in both the preoperative planning and the intra-operative surgical phases of dental implantation surgery. The system provides precise navigational guidance of surgical instruments such as a dental bur, with regard to the pre-operative planning in the dental implantation procedure.

Source page: https://510kreport.com/device/K061224
Methodology: https://510kreport.com/methodology