510(k) · Cleared
Cleared15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM, 15 Esthetic Abutment Nobelactive
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 Jun 23, 2011 as substantially equivalent to K102436 (Nobel Biocare AB, 2010) after a 16-day review. Its family tree reaches back 9 generations to 1990. 4 later devices descend from it.
- Decided
- Jun 23, 2011
- Review
- 16 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 23 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- This deviceK111581 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment…Nobel Biocare AB · 2011
- Descendant · cites it directly · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · cites it directly · 1 of its ownK123386 Periotype X-PertClinical House Europe GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK151169 OsteoReady ZircoSeal AbutmentsOsteoready, LLC · 2015
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- This deviceK111581 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment…Nobel Biocare AB · 2011
Most influential descendants
Showing 4 of 4 · See all- K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · cites it directly1descendant
- K123386Periotype X-PertClinical House Europe GmbH · 2013 · cites it directly1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
- K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| 0 (this device) | K111581 | 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive… | Nobel Biocare AB | 2011 | — |
| +1 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +1 | K123386 | Periotype X-Pert | Clinical House Europe GmbH | 2013 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
| +2 | K151169 | OsteoReady ZircoSeal Abutments | Osteoready, LLC | 2015 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K102436 | Nobel Active 3.0Summary page 1…ment (21 CFR 872:3630) Trade or Proprietary or Model Name: NobelActive 3.0 Angled Abutment Legally Marketed Devices: Nobel Biocare - NobelActive 3.0 (102436) Device Description: The NobelActive 3.0 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare Nobel… | 2010 |
What descends from it? (4)
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K213576 (Suncoast Dental, Inc. Dba Tatum Surgical, 2022) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K102436.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
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 as stated in the FDA summary.
https://510kreport.com/device/K111581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111581: 15 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM, 15 Esthetic Abutment Nobelactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111581
Report an extraction error
Are you the manufacturer?
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