510(k) · Cleared
ClearedD-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neks Technologies, Inc. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Mar 30, 2007 as substantially equivalent to K991098 (Electro-Optical Sciences, Inc., 1999) and 3 other predicates after a 148-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Mar 30, 2007
- Review
- 148 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to DEN980003 (1998). 9 ancestors in all, the oldest K933455 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- 2 generations backK023367 Detectar, Model N123-MINeks Technologies · 2003
- 1 generation backK043156 D-Carie, Model N121-M1Neks Technologies, Inc. · 2005
- This deviceK063321 D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138Neks Technologies, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| −2 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| −1 | K043156 | D-Carie, Model N121-M1 | Neks Technologies, Inc. | 2005 | — |
| 0 (this device) | K063321 | D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBL device
- #1 K252464 Surgical Microscope (OMS2360, OMS2380)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991098 | Difoti SystemSummary page 1…D-Carie/Detectar Models : N121, N123, N133, N134, N135 &N1 38 2. Predicate Devices: DIFOTI System for Dental Examinations, Electro-Optical Sciences, Inc.(K991 098) Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems- preamendment, various manufacturers (51 0(k… | 1999 |
| * | K050019 | IN Exam Intraoral Dental X-Ray SystemSummary page 1…(FOTI) fiberoptic dental imaging systems- preamendment, various manufacturers (51 0(k) exempt) IN EXAM INTRAORAL DENTAL X-RAY SYSTEM, Kayo America (K050019) and other dental X-Rays System from various manufacturers. Dental explorer for clinical examination, various manufacturer… | 2005 |
| * | K043156 | D-Carie, Model N121-M1Summary page 1…various manufacturers. Dental explorer for clinical examination, various manufacturer (51 0(k) exempt) D-CARIE, MODEL NI 21 -MI, Neks Technologies (K0431 56) DETECTAR, MODEL N1 23-MI, Neks Technologies (K023367) 3. Device Description and Intended Use: The indication of u… | 2005 |
| * | K023367 | Detectar, Model N123-MISummary page 1…amination, various manufacturer (51 0(k) exempt) D-CARIE, MODEL NI 21 -MI, Neks Technologies (K0431 56) DETECTAR, MODEL N1 23-MI, Neks Technologies (K023367) 3. Device Description and Intended Use: The indication of use of the D-Carie is extended to include aid for diagn… | 2003 |
| * | — | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems—preamendment… Named without a submission number | |
| * | — | Other dental X-ray systems from various manufacturers Named without a submission number | |
| * | — | Dental explorer for clinical examination, various manufacturers Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K991098.
How does its category compare?
All NBL devicesNBL Light-Induced Fluorescence Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBL
Too few NBL 510(k)s in any year since 2007 to give a median.
Recalls per year · NBL
No recall names NBL since 2007.
Adverse event reports per year · NBL
1in 2020
MAUDE reports naming product code NBL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063321: D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026