510(k) · Cleared
ClearedProcera Software, Model 33145
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 10, 2006 as substantially equivalent to K030685 (Nobel Biocare AB, 2004) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 2000. 248 later devices descend from it.
- Decided
- Feb 10, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000018 (2000). 4 ancestors in all. 248 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000018 Branemark NovumNobel Biocare Uas, Inc. · 2000
- 2 generations backK030685 Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004 · Recalled
- 1 generation backK050393 The Guided Surgery ConceptNobel Biocare AB · 2005
- This deviceK053602 Procera Software, Model 33145Nobel Biocare AB · 2006
- Descendant · cites it directly · 242 of its ownK062493 Lava Software3M Espe AG Dental Products · 2006
- Descendant · 2 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · cites it directly · 169 of its ownK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- Descendant · 2 generations on · 167 of its ownK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 248 · See all- K062493Lava Software3M Espe AG Dental Products · 2006 · cites it directly242descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 2 generations on240descendants
- K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009 · cites it directly169descendants
- K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010 · 2 generations on167descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000018 | Branemark Novum | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K030685 | Teeth in an Hour - Ark Implant Concept | Nobel Biocare AB | 2004 | 1 |
| −1 | K050393 | The Guided Surgery Concept | Nobel Biocare AB | 2005 | — |
| 0 (this device) | K053602 | Procera Software, Model 33145 | Nobel Biocare AB | 2006 | — |
| +1 | K062493 | Lava Software | 3M Espe AG Dental Products | 2006 | — |
| +2 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +1 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| +2 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 13 | 0 |
| 2017 | 11 | 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? (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 |
|---|---|---|---|
| * | K030685 | Teeth in an Hour - Ark Implant ConceptSummary page 1…FA 872.3640) Trade or Proprietary or Model Name: Procera®~ Software Legally Marketed Device(s): Nobel Biocare - Teeth in an Hour (K030685) Nobel Biocare - Guided Surgery (K050393) Device Description: The Procera Client Mana… | 2004 |
| * | K050393 | The Guided Surgery ConceptSummary page 1…a®~ Software Legally Marketed Device(s): Nobel Biocare - Teeth in an Hour (K030685) Nobel Biocare - Guided Surgery (K050393) Device Description: The Procera Client Management System (POMS) software is intended to be used by dental practitioners and d… | 2005 |
What descends from it? (248)
See all 2483 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 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K062493 (3M Espe AG Dental Products, 2006) has gone furthest, with 242 descendants of its own.
- 1 other device also cites its predicate K030685.
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?
Nobel Biocare's Procera Software imports patient specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings, laminates, and bridges through the use of a 3D-CAD tool. The software also serves as a means of ordering and managing orders of Procera products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053602: Procera Software, Model 33145.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053602
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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