510(k) · Cleared
Recalled · Class II · 2018Nobelactive Multi Unit Abutment
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 Dec 28, 2007 as substantially equivalent to K062749 (Nobel Biocare AB, 2006) and 1 other predicate after a 107-day review. Its family tree reaches back 8 generations to 1990. 181 later devices descend from it. It has been recalled once.
- Decided
- Dec 28, 2007
- Review
- 107 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894595 (1990). 22 ancestors in all. 181 later devices descend from it, 18 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 backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- This deviceK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007
- Descendant · cites it directly · 74 of its ownK161416 Multi-unit Abutment PlusNobel Biocare AB · 2017
- Descendant · cites it directly · 64 of its ownK111935 TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 35 of its ownK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- Descendant · cites it directly · 34 of its ownK093643 Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K161416Multi-unit Abutment PlusNobel Biocare AB · 2017 · cites it directly74descendants
- K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012 · cites it directly64descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC · 2014 · 2 generations on35descendants
- K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010 · cites it directly34descendants
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 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | — |
| +1 | K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | 2017 | — |
| +1 | K111935 | TI-Base Abutment, 1 Connect Abutment | Nt-Trading GmbH and CO KG | 2012 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| +1 | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | Nobel Biocare AB | 2010 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 22 | 0 |
| 2022 | 20 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 15 | 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 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 |
|---|---|---|---|
| * | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Summary page 1…82-4800, ext. 7842 (714) 262-8023 September 10, 2007 Endosseous dental implant abutment (21 CFR 872.3630) NobelActive Multi Unit Abutment SFB & CFB Angled Abutments (K062749) SFB and CFB Implant System (K061003) NcbelActive Multi Unit Abutments are artificial tooth abutments designed to fit and functi… | 2006 |
| * | K061003 | SFB & CFB ImplantsSummary page 1…ptember 10, 2007 Endosseous dental implant abutment (21 CFR 872.3630) NobelActive Multi Unit Abutment SFB & CFB Angled Abutments (K062749) SFB and CFB Implant System (K061003) NcbelActive Multi Unit Abutments are artificial tooth abutments designed to fit and function on the NobefActive Implants. It is… | 2006 |
What descends from it? (181)
See all 18118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161416 | Multi-unit Abutment Plus | 2017 | 74 |
| K111935 | TI-Base Abutment, 1 Connect Abutment | 2012 | 64 |
| K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | 2010 | 34 |
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K170398 | S.I.N. Dental Implant System | 2017 | 17 |
| K170392 | S.I.N. Implant System | 2017 | 16 |
| K123491 | Biodenta Dental Implant System - Multi-Use Abutment | 2013 | 11 |
| K182448 | AnyRidge Octa 1 Implant System | 2019 | 9 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | 2017 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2018 | Class II | Z-2529-2018 | Nonconforming Material/Component | The product label has missing information, such as the lot number and expiration date, as well as other information. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K161416 (Nobel Biocare AB, 2017) has gone furthest, with 74 descendants of its own.
- 3 other devices also cite its predicate K062749.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
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/K072570 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072570: Nobelactive Multi Unit Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072570
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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