510(k) · Cleared
ClearedTRIOS Ready Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Shape TRIOS A/S · NBL Light-Induced Fluorescence Caries Detector
Cleared on Apr 4, 2025 as substantially equivalent to K221249 (3Shape TRIOS A/S, 2022) after a 260-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 4, 2025
- Review
- 260 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN990002 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 4 generations backK040063 Inspektor ProInspektor Dental Care BV · 2004
- 3 generations backK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- 2 generations backK150672 VistaCam iX ProofDurr Dental AG · 2016
- 1 generation backK221249 L1P-1F (Trios 5)3Shape TRIOS A/S · 2022
- This deviceK242103 TRIOS Ready Tip3Shape TRIOS A/S · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| −4 | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| −3 | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| −2 | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| −1 | K221249 | L1P-1F (Trios 5) | 3Shape TRIOS A/S | 2022 | — |
| 0 (this device) | K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025 | — |
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? (1)
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 |
|---|---|---|---|
| * | K221249 | L1P-1F (Trios 5)Summary page 5…r 872.1745 Product Code(s) NBL I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221249 TRIOS 5 (L1P-1F) NBL Device Description Summary 21 CFR 807.92(a)(4) The L1P-1F intraoral scanner (IOS) system is intended for ai… | 2022 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
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. 2025, 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?
The Li P-1 F intraoral scanner (lOS) system is intended for aid in diagnosis of caries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242103: TRIOS Ready Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242103
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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