510(k) · Cleared
ClearedNobelprocera TI 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 Sep 22, 2009 as substantially equivalent to K042658 (Nobel Biocare Uas, Inc., 2004) and 2 other predicates after a 98-day review. Its family tree reaches back 8 generations to 1990. 278 later devices descend from it.
- Decided
- Sep 22, 2009
- Review
- 98 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894595 (1990). 73 ancestors in all, the oldest K871863 (1987). 278 later devices descend from it, 10 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 deviceK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · cites it directly · 101 of its ownK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- Descendant · 2 generations on · 99 of its ownK142260 NobelActiveNobel Biocare AB · 2015
Showing 5 of 278 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 278 · See all- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K133731Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014 · cites it directly101descendants
- K142260NobelActiveNobel Biocare AB · 2015 · 2 generations on99descendants
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) | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| +1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +1 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| +2 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 12 | 0 |
| 2015 | 15 | 0 |
| 2016 | 14 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 23 | 0 |
| 2021 | 26 | 0 |
| 2022 | 21 | 0 |
| 2023 | 31 | 0 |
| 2024 | 37 | 0 |
| 2025 | 28 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…Trade or Proprietary or Model Name: NobelProcera Ti Abutment Legally Marketed Devices: Nobel Biocare - Procera® Abutment Brinemark (K042658) Nobel Biocare - Procera® Implant Bridge Overdenture (K090064) No… | 2004 |
| * | K090069 | Procera Implant Bridge Overdenture Our reading of the summary gave K090064, FDA’s number for Eminent Spine Interbody Fusion System (Eminent Spine). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nobel Biocare - Procera® Implant Bridge Overdenture”. | 2009 |
| * | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Summary page 1…Nobel Biocare - Procera® Implant Bridge Overdenture (K090064) Nobel Biocare - SFB and CFB Angled Abutments (K062749) Device Description: Nobel Biocare's NobelProcera Ti Abutment is an endosseous dental implant abutment. The N… | 2006 |
What descends from it? (278)
See all 27810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100152 | Sirona Cad/Cam System | 2010 | 240 |
| K133731 | Nobelactive Wide Platform (WP) | 2014 | 101 |
| K111421 | Sirona Dental Cad/Cam System | 2012 | 54 |
| K120873 | Zimmer ZFX Abutment for Nobel Replace Implant System | 2012 | 16 |
| K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant… | 2014 | 14 |
| K113738 | Creodent Solidex Custom Abutment | 2013 | 7 |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | 2024 | 2 |
| K142115 | Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant | 2014 | 2 |
| K101714 | Nobelprocera TI Abutment Thommen Platforms | 2010 | 1 |
| K122602 | Nobelprocera TI Abutment Camlog Platforms | 2013 | 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 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 73 ancestors have a recall of any class.
- Of its descendants, K100152 (Sirona Dental Systems GmbH, 2010) has gone furthest, with 240 descendants of its own.
- 9 other devices also cite its predicate K042658.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous 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/K091756 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091756: Nobelprocera TI Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091756
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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