510(k) · Cleared
ClearedEsthetic Abutments Nobel Biocare N1
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 Sep 16, 2022 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) and 1 other predicate after a 221-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Sep 16, 2022
- Review
- 221 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894595 (1990). 24 ancestors in all. No later device cites it as a predicate yet.
- 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 backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK220339 Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG · 2022
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 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K220339 | Esthetic Abutments Nobel Biocare N1 | Nobel Biocare Services AG | 2022 | — |
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 |
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 5…Page 1 of 19 iii. Predicate Devices Primary Predicate Device Propriety Name: NobelActive Internal Connection Implant (K071370) Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Impla… | 2007 |
| * | K161655 | On1 ConceptSummary page 5…ment Regulation Number: 21 CFR§872.3630 Device Class: Class II Product Code: DZE, NHA Predicate Device #2 Propriety Name: On1 Concept (K161655) Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Im… | 2017 |
| † | K211109 | N1 TiUltra TCC Implant System | 2021 |
| † | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.9 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 28 other devices also cite its predicate K071370.
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?
Esthetic Abutment Nobel Biocare Nl TM TCC:
The Esthetic Abutment Nobel Biocare Nl TM TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutment Nobel Biocare Nl TM Base:
The Esthetic Abutment Nobel Biocare Nl TM Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220339: Esthetic Abutments Nobel Biocare N1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220339
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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