510(k) · Cleared
ClearedAngled Xive MP Abutment, Angled Ankylos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 11, 2012 as substantially equivalent to K050406 (Nobel Biocare AB, 2005) and 2 other predicates after a 134-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 134 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894595 (1990). 25 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 2 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 1 generation backK050406 Nobelspeedy ImplantsNobel Biocare AB · 2005
- This deviceK122268 Angled Xive MP Abutment, Angled AnkylosDentsply International · 2012
- Descendant · cites it directly · 1 of its ownK131644 Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK151439 Atlantis IsusDentsply International, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050406 | Nobelspeedy Implants | Nobel Biocare AB | 2005 | — |
| 0 (this device) | K122268 | Angled Xive MP Abutment, Angled Ankylos | Dentsply International | 2012 | — |
| +1 | K131644 | Ankylos Syncone Abutment 5(Degree) | Dentsply International, Inc. | 2014 | — |
| +2 | K151439 | Atlantis Isus | Dentsply International, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K050406 | Nobelspeedy ImplantsSummary page 1…3. Predicate Device: TM *Angled Multi-Unit Abutments cleared in K050406 (NOBELSPEEDY Implants) * Straight ANKYLOS® Balance Base Abutments cleared in K073075… | 2005 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 1…*Angled Multi-Unit Abutments cleared in K050406 (NOBELSPEEDY Implants) * Straight ANKYLOS® Balance Base Abutments cleared in K073075 *(FRIADENT Implant Systems) *Straight FRIADENTO MP Abutments cleared in K994 174 (FRIALIT-2®… | 2008 |
| * | K994174 | Frialit-2 MH-2 AbutmentSummary page 1…Straight ANKYLOS® Balance Base Abutments cleared in K073075 *(FRIADENT Implant Systems) *Straight FRIADENTO MP Abutments cleared in K994 174 (FRIALIT-2®1 MH-2 ABUTMENT) 4. Description of Device: The Angled XiVE® MP and ANKYLOS® Balan… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131644 | Ankylos Syncone Abutment 5(Degree) | 2014 | 1 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K131644 (Dentsply International, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K050406.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30 and 45° in edentulous arch, a minimum of four implants must be used and splinted.…
Read the full statement (123 words)
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30 and 45° in edentulous arch, a minimum of four implants must be used and splinted.
The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122268 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122268: Angled Xive MP Abutment, Angled Ankylos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122268
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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