510(k) · Cleared
Cleared3M True Definition Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Cleared on Nov 20, 2012 as substantially equivalent to K073199 (Brontes Technologies, 2007) and 1 other predicate after a 99-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 20, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- NOF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K994172 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK994172 CEREC 3Sirona Dental Systems GmbH · 2000
- 2 generations backK073199 3M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007
- 1 generation backK081961 3M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008
- This deviceK122467 3M True Definition Scanner3M Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 2…Page 1 of 7 Predicate Devices: 3MTM ESPETM Lava Chairside Oral Scanner (C.O.S.), K073 199 3MTM Unitek Tm Lava Chairside Oral Scanner (C.O.S.), K08 1961 Description of Device:… | 2007 |
| * | K081961 | 3M Unitek Lava Chairside Oral ScannerSummary page 2…Predicate Devices: 3MTM ESPETM Lava Chairside Oral Scanner (C.O.S.), K073 199 3MTM Unitek Tm Lava Chairside Oral Scanner (C.O.S.), K08 1961 Description of Device: The 3M True Definition Scanner is a digital impression generating system… | 2008 |
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 12 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- 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. 2012, 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?
3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate). The three dimensional (3D) model generated from the scan may be further used for the…
Read the full statement (110 words)
3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).
The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth.
It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122467: 3M True Definition Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122467
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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