510(k) · Cleared
ClearedLythos Digital Impression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Cleared on Dec 5, 2014 as substantially equivalent to K122065 (Ormco Corp., 2013) after a 172-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 5, 2014
- Review
- 172 days
- Class
- Class II
- Product code
- NOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K994172 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK994172 CEREC 3Sirona Dental Systems GmbH · 2000
- 3 generations backK073199 3M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007
- 2 generations backK081961 3M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008
- 1 generation backK122065 Digital Impression System for Orthodontic UseOrmco Corp. · 2013
- This deviceK141611 Lythos Digital Impression SystemOrmco Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000 | — |
| −3 | K073199 | 3M Espe Lava Chairside Oral Scanner | Brontes Technologies | 2007 | — |
| −2 | K081961 | 3M Unitek Lava Chairside Oral Scanner | Brontes Technologies | 2008 | — |
| −1 | K122065 | Digital Impression System for Orthodontic Use | Ormco Corp. | 2013 | — |
| 0 (this device) | K141611 | Lythos Digital Impression System | Ormco Corp. | 2014 | — |
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 NOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K122065 | Digital Impression System for Orthodontic UseSummary page 4…3. Predicate Device: The Lythos Digital Impression System is substantially equivalent to the legally marketed device Digital Impression System K122065 cleared on February 8, 2013, product code NOF. 4. Description of Device: The Lythos Digital Impressio… | 2013 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All NOF devicesNOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NOF
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NOF
Too few NOF 510(k)s in any year since 2007 to give a median.
Recalls per year · NOF
No recall names NOF since 2007.
Adverse event reports per year · NOF
3in 2025
MAUDE reports naming product code NOF, 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 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141611: Lythos Digital Impression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141611
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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