510(k) · Cleared
ClearedLava Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 17, 2006 as substantially equivalent to K053602 (Nobel Biocare AB, 2006) after an 84-day review. Its family tree reaches back 4 generations to 2000. 242 later devices descend from it.
- Decided
- Nov 17, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000018 (2000). 5 ancestors in all. 242 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK000018 Branemark NovumNobel Biocare Uas, Inc. · 2000
- 3 generations backK030685 Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004 · Recalled
- 2 generations backK050393 The Guided Surgery ConceptNobel Biocare AB · 2005
- 1 generation backK053602 Procera Software, Model 33145Nobel Biocare AB · 2006
- This deviceK062493 Lava Software3M Espe AG Dental Products · 2006
- Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 242 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 242 · See all- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000018 | Branemark Novum | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K030685 | Teeth in an Hour - Ark Implant Concept | Nobel Biocare AB | 2004 | 1 |
| −2 | K050393 | The Guided Surgery Concept | Nobel Biocare AB | 2005 | — |
| −1 | K053602 | Procera Software, Model 33145 | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K062493 | Lava Software | 3M Espe AG Dental Products | 2006 | — |
| +1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 12 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 22 | 0 |
| 2022 | 19 | 0 |
| 2023 | 31 | 0 |
| 2024 | 34 | 0 |
| 2025 | 27 | 0 |
| 2026 | 14 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K053602 | Procera Software, Model 33145Summary page 2…All-ceramic overlay material Predicate Device: Procera® Software by Nobel Biocare USA LLC, K053602 Description for the Premarket Notification The LavaTM software is used with 3M ESPE's LavaT… | 2006 |
What descends from it? (242)
See all 2423 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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K100152 (Sirona Dental Systems GmbH, 2010) has gone furthest, with 240 descendants of its own.
- 2 other devices also cite its predicate K053602.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.
The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.
The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062493: Lava Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062493
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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