# K042212: Implantmaster

- Pathway: 510(k) (Traditional)
- Applicant: I-Dent
- Decided: Oct 21, 2004 after 66 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924630 (1993). 4 ancestors in all.
44 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004). Our reading of the summary gave K033847, FDA’s number for A1CNOW for Home and Professional Use (Metrika, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SimPlant system”.

## Most influential descendants
- K060267: Virtual Implant Placement (Vip) Dental  Implant Surgery Planning Software (2006), 43 descendants of its own
- K070803: Invivodental (2007), 38 descendants of its own
- K123519: Invivo  Dental (2013), 24 descendants of its own
- K140713: Planmeca Romexis (2014), 14 descendants of its own
- K162799: Cliniview (2017), 13 descendants of its own

## Indications for use
The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.

Source page: https://510kreport.com/device/K042212
Methodology: https://510kreport.com/methodology