# K023367: Detectar, Model N123-MI

- Pathway: 510(k) (Traditional)
- Applicant: Neks Technologies
- Decided: Jun 25, 2003 after 260 days
- Product code: EJB (Handle, Instrument, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN980003 (1998). 3 ancestors in all.
31 later devices descend from it; 3 cite 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)
- DEN980003: Diamond Probe/Perio 2000 System, Diamond General Development Corp. (1998). Our reading of the summary gave K980749, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980003, Diamond Probe/Perio 2000 System (Diamond General Development Corp.), granted Jul 17, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K982480: Perioview Model DV-1 Fiberscope and Window Sheath., Dentalview, Inc. (1998) 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.
- (no number) Manual periodontal probes: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K973490: Sunglasses, Tong Yang Optical Co. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K973638: N.I.T., Inc. Needle Guiding Template, Avid N.I.T., Inc. (1997). Our reading of the summary gave K973638, FDA’s number for N.I.T., Inc. Needle Guiding Template (Avid N.I.T., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alpha 4 LS Automated Microtiterplate Processor”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K042394: Diagnodent Perio Tip (Accessory) (2005), 28 descendants of its own
- K060080: Diagnodent 2190 with Periodontal Probe (2006), 27 descendants of its own
- K073074: Key Laser Iii 1243 US with Detect (2008), 26 descendants of its own
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own

## Indications for use
DETECTAR is indicated for the detection of subgingival dental calculus

Source page: https://510kreport.com/device/K023367
Methodology: https://510kreport.com/methodology