510(k) · Cleared
ClearedDigital Impression System for Orthodontic Use
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 Feb 8, 2013 as substantially equivalent to K081961 (Brontes Technologies, 2008) after a 210-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Feb 8, 2013
- Review
- 210 days
- Class
- Class II
- Product code
- NOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K994172 (2000). 1 later device descends from it, 1 citing it directly.
- 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 deviceK122065 Digital Impression System for Orthodontic UseOrmco Corp. · 2013
- Descendant · cites it directly · 0 of its ownK141611 Lythos Digital Impression SystemOrmco Corp. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141611Lythos Digital Impression SystemOrmco Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000 | — |
| −2 | K073199 | 3M Espe Lava Chairside Oral Scanner | Brontes Technologies | 2007 | — |
| −1 | K081961 | 3M Unitek Lava Chairside Oral Scanner | Brontes Technologies | 2008 | — |
| 0 (this device) | K122065 | Digital Impression System for Orthodontic Use | Ormco Corp. | 2013 | — |
| +1 | K141611 | Lythos Digital Impression System | Ormco Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K081961 | 3M Unitek Lava Chairside Oral ScannerSummary page 1…(CAD/CAM) of Dental Restorations (INOF) Devices for Which Substantial Equivalence isClaimed: *3M Unitek Lava Oiairside Oral Scanner, Bran tes Technologies, Inc. K(081961 Device Description: The Digital,Impression System.far'Orthodontic: Use (DIS) isa handheld iritraloial-3D imager Intended for us… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141611 | Lythos Digital Impression System | 2014 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141611 (Ormco Corp., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081961.
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. 2013, 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 Digital Impression System for Orthodontic Use is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva and/or palate. The Digital Impression System is intended for use in conjunction with the production of orthodontic appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122065: Digital Impression System for Orthodontic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122065
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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