510(k) · Cleared
ClearedMulti- Unit Abutments for Straumann and Astra Tech Implant Systems
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 24, 2010 as substantially equivalent to K061477 (Nobel Biocare AB, 2006) and 4 other predicates after a 211-day review. Its family tree reaches back 9 generations to 1990. 34 later devices descend from it.
- Decided
- Jun 24, 2010
- Review
- 211 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K894595 (1990). 59 ancestors in all, the oldest K894844 (1990). 34 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 backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK093643 Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK142167 Medentika Abutment SystemMedentika GmbH · 2015
- Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
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 backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK093643 Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
- K142167Medentika Abutment SystemMedentika GmbH · 2015 · cites it directly7descendants
- K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
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 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −1 | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | 1 |
| 0 (this device) | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | Nobel Biocare AB | 2010 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +1 | K142167 | Medentika Abutment System | Medentika GmbH | 2015 | — |
| +2 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsSummary page 1…and AstraTech Implant Systems Legally Marketed Device(s): Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems (K061477) NobelActive Multi Unit Abutments (K072570) OsseoSpeed Profile… | 2006 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 1…butments for Astra Tech, Camlog and Ankylos Implant Systems (K061477) NobelActive Multi Unit Abutments (K072570) OsseoSpeed Profile Systems (K0801 56) SLActive Implants (K0530… | 2007 |
| * | K080156 | Osseospeed TM Profile SystemSummary page 1…Systems (K061477) NobelActive Multi Unit Abutments (K072570) OsseoSpeed Profile Systems (K0801 56) SLActive Implants (K053088) P.004 Implants (K062129) Device De… | 2008 |
| * | K053088 | Slactive ImplantsSummary page 1…NobelActive Multi Unit Abutments (K072570) OsseoSpeed Profile Systems (K0801 56) SLActive Implants (K053088) P.004 Implants (K062129) Device Description: Nobel Biocare's Multi-Unit Abutments for Straumann… | 2006 |
| * | K062129 | P.0004 ImplantsSummary page 1…OsseoSpeed Profile Systems (K0801 56) SLActive Implants (K053088) P.004 Implants (K062129) Device Description: Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental impla… | 2006 |
What descends from it? (34)
See all 342 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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 59 ancestors have a recall of any class.
- Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K061477.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endlosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093643 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093643
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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