510(k) · Cleared
Cleared3M Unitek Lava Chairside Oral Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brontes Technologies · NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Cleared on Sep 5, 2008 as substantially equivalent to K073199 (Brontes Technologies, 2007) after a 58-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- NOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K994172 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK994172 CEREC 3Sirona Dental Systems GmbH · 2000
- 1 generation backK073199 3M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007
- This deviceK081961 3M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008
- Descendant · cites it directly · 1 of its ownK122065 Digital Impression System for Orthodontic UseOrmco Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK141611 Lythos Digital Impression SystemOrmco Corp. · 2014
- Descendant · cites it directly · 0 of its ownK122467 3M True Definition Scanner3M Company · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000 | — |
| −1 | K073199 | 3M Espe Lava Chairside Oral Scanner | Brontes Technologies | 2007 | — |
| 0 (this device) | K081961 | 3M Unitek Lava Chairside Oral Scanner | Brontes Technologies | 2008 | — |
| +1 | K122065 | Digital Impression System for Orthodontic Use | Ormco Corp. | 2013 | — |
| +2 | K141611 | Lythos Digital Impression System | Ormco Corp. | 2014 | — |
| +1 | K122467 | 3M True Definition Scanner | 3M Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K073199 | 3M Espe Lava Chairside Oral ScannerSummary page 1…ers and Product Codes of equivalent devices: Brontes Technologies, Inc. (A3M Company), Lexington, MA 3M TM ESPE Lava TM Chairside Oral Scanner Code: NOF; K073199 Indications for Use The 3MTM UnitekTM Lava Tm Chairside Oral Scanner is an optical impression system (CAD/CAM) us… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122065 (Ormco Corp., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K073199.
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. 2008, 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 3M Unitek Lava Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M Unitek Lava Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081961: 3M Unitek Lava Chairside Oral Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081961
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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