510(k) · Cleared
ClearedNobel Active 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Dec 9, 2010 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) after a 105-day review. Its family tree reaches back 8 generations to 1990. 203 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 22 ancestors in all. 203 later devices descend from it, 14 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- Descendant · cites it directly · 99 of its ownK142260 NobelActiveNobel Biocare AB · 2015
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 54 of its ownK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 39 of its ownK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- K142260NobelActiveNobel Biocare AB · 2015 · cites it directly99descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012 · cites it directly54descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013 · 2 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| +1 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 21 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 0 |
| 2024 | 22 | 0 |
| 2025 | 25 | 0 |
| 2026 | 15 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…eous Dental implant Abutment (21 CFR 872.3630) Trade or Proprietary or Model Name: NobelActive 3.0 Legally Marketed Device(s): NobelActive Intemal Connection Implant (K071370) Device Description: Nobel Biocare’s NobelActive 3.0 is an endosseous dental implant and abutment system. The implant is 3.0 mm… | 2007 |
What descends from it? (203)
See all 20314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142260 | NobelActive | 2015 | 99 |
| K111421 | Sirona Dental Cad/Cam System | 2012 | 54 |
| K112440 | AB Dental Devices Implants and Accessories | 2012 | 36 |
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 | 10 |
| K111581 | 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM… | 2011 | 4 |
| K123512 | Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM | 2013 | 2 |
| K110548 | Osi O-Ball Abutment Head Implants | 2011 | 2 |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | 2016 | 1 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC… | 2026 | 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 20 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K142260 (Nobel Biocare AB, 2015) has gone furthest, with 99 descendants of its own.
- 28 other devices also cite its predicate K071370.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The NobelActive. 3.0mm implant Is indicated for use In the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102436: Nobel Active 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102436
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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