510(k) · Cleared
ClearedNobelProcera Zirconia N1 Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Services AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 29, 2022 as substantially equivalent to K161655 (Nobel Biocare AB, 2017) and 1 other predicate after a 204-day review. Its family tree reaches back 14 generations to 1990. 1 later device descends from it.
- Decided
- Jul 29, 2022
- Review
- 204 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K894595 (1990). 99 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- 2 generations backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- 1 generation backK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- This deviceK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- Descendant · cites it directly · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 10 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 9 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 8 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 7 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 6 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 5 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 4 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 3 generations backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- 2 generations backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- 1 generation backK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- This deviceK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
Most influential descendants
Showing 1 of 1 · See all- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −10 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −9 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −8 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −7 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −6 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −5 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −4 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| −3 | K173418 | NobelParallel Conical Connection | Nobel Biocare AB | 2019 | 1 |
| −2 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| −1 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| 0 (this device) | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
| +1 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K161655 | On1 ConceptSummary page 5…NHA Page 1 of 24 510(k) SUMMARY (CONT.) 3. Predicate Device Primary Predicate Propriety Name: On1 Concept (K161655) Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Impla… | 2017 |
| * | K211109 | N1 TiUltra TCC Implant SystemSummary page 5…21 CFR 872.3630 Device Class: Class II Product Code: NHA Reference Device No. 1 Proprietary Name: N1™ TiUltra™ TCC Implant system (N1™ system; K211109) Manufacturer: Nobel Biocare AB Common Name: Dental Implants Classification Name: Endosseous Dental Implant… | 2021 |
| † | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical Connection | 2014 |
| † | K143071 | Nacera Pearl | 2015 |
| † | K202452 | NobelProcera Zirconia Implant Bridge | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC… | 2026 | 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 32 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 99 ancestors have a recall of any class.
- Of its descendants, K253999 (Nobel Biocare AB, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K161655.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220048: NobelProcera Zirconia N1 Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220048
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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