510(k) · Cleared
ClearedNobelreplace Adapter, Model 32412
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 7, 2005 as substantially equivalent to K021584 (Nobel Biocare Uas, Inc., 2002) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jul 7, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962845 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
- 4 generations backK021584 Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc. · 2002
- 3 generations backK030257 Nobel Perfect Implant SystemNobel Biocare Uas, Inc. · 2003
- 2 generations backK033724 Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc. · 2004
- 1 generation backK040573 Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc. · 2004
- This deviceK050444 Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK063592 Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS…Nobel Biocare AB · 2007
Most influential descendants
Showing 1 of 1 · See all- K063592Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553…Nobel Biocare AB · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962845 | Replace HA Coated Implants | Steri-Oss, Inc. | 1996 | — |
| −4 | K021584 | Replace Scalloped Margin Implant System | Nobel Biocare Uas, Inc. | 2002 | — |
| −3 | K030257 | Nobel Perfect Implant System | Nobel Biocare Uas, Inc. | 2003 | — |
| −2 | K033724 | Nobel Biocare Centric Post, Models 31234, 31235 and 31236 | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K040573 | Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236 | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K050444 | Nobelreplace Adapter, Model 32412 | Nobel Biocare Uas, Inc. | 2005 | — |
| +1 | K063592 | Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP… | Nobel Biocare AB | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K021584 | Replace Scalloped Margin Implant SystemSummary page 1…Trade or Proprietary or Model Name: NOBELREPLACE® Adapter Legally Marketed Device(s): Replace Scalloped Margin Implant System (K021584) Nobel Biocare Permanent Centric Post (K040573) Device Description: Nobel Biocare's… | 2002 |
| * | K040573 | Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Summary page 1…gally Marketed Device(s): Replace Scalloped Margin Implant System (K021584) Nobel Biocare Permanent Centric Post (K040573) Device Description: Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory… | 2004 |
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 |
|---|---|---|---|
| K063592 | Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553… | 2007 | 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 9 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063592 (Nobel Biocare AB, 2007) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K021584.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller
diameter abutment to a larger diameter endosseous implant in an implant-supported dental
restoration of a partially or fully edentulous jaw in order to restore patient esthetics and
chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050444: Nobelreplace Adapter, Model 32412.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050444
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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