510(k) · Cleared
ClearedCEREC 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · ELW Material, Impression
Cleared on Feb 8, 2000 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Feb 8, 2000
- Review
- 60 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK994172 CEREC 3Sirona Dental Systems GmbH · 2000
- Descendant · cites it directly · 4 of its ownK073199 3M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007
- Descendant · 2 generations on · 3 of its ownK081961 3M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008
- Descendant · 3 generations on · 1 of its ownK122065 Digital Impression System for Orthodontic UseOrmco Corp. · 2013
- Descendant · 4 generations on · 0 of its ownK141611 Lythos Digital Impression SystemOrmco Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK122467 3M True Definition Scanner3M Company · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K0731993M Espe Lava Chairside Oral ScannerBrontes Technologies · 2007 · cites it directly4descendants
- K0819613M Unitek Lava Chairside Oral ScannerBrontes Technologies · 2008 · 2 generations on3descendants
- K122065Digital Impression System for Orthodontic UseOrmco Corp. · 2013 · 3 generations on1descendant
- K141611Lythos Digital Impression SystemOrmco Corp. · 2014 · 4 generations on0descendants
- K1224673M True Definition Scanner3M Company · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000 | — |
| +1 | K073199 | 3M Espe Lava Chairside Oral Scanner | Brontes Technologies | 2007 | — |
| +2 | K081961 | 3M Unitek Lava Chairside Oral Scanner | Brontes Technologies | 2008 | — |
| +3 | K122065 | Digital Impression System for Orthodontic Use | Ormco Corp. | 2013 | — |
| +4 | K141611 | Lythos Digital Impression System | Ormco Corp. | 2014 | — |
| +2 | K122467 | 3M True Definition Scanner | 3M Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
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?
- Of its descendants, K073199 (Brontes Technologies, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
The CEREC® 3 System is intended to be used in the computer-aided desigu and miuing of ceramic dental restorations, including inlays, onlays, veneers, partial crowms, and full crowns.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994172: CEREC 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994172
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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