# K073074: Key Laser Iii 1243 US with Detect

- Pathway: 510(k) (Special)
- Applicant: Kavo America
- Decided: Jul 10, 2008 after 253 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN980003 (1998). 8 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030146: Kavo Key Laser 1242 and Kavo Key Laser 1243+, Kavo America (2005) Summary page 1.
- DEN990002: Kavo Diagnodent, Kavo America (2000). Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K042394: Diagnodent Perio Tip (Accessory), Kavo America Corporation (2005) Summary page 1.
- K051909: Diagnodent, Kavo America (2005) Summary page 1.
- K060080: Diagnodent 2190 with Periodontal Probe, Kavo Dental Corporation (2006) Summary page 1.

## Most influential descendants
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own
- K190319: Waterlase Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K193661: LightWalker Laser System Family (2020), 8 descendants of its own

## Indications for use
For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243..

Source page: https://510kreport.com/device/K073074
Methodology: https://510kreport.com/methodology