510(k) · Cleared
ClearedAdapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553, Abutment Screw PS WP-RP, 34554
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 Feb 27, 2007 as substantially equivalent to K031719 (Nobel Biocare AB, 2003) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Feb 27, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962845 (1996). 8 ancestors in all, the oldest K913255 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
- 5 generations backK021584 Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc. · 2002
- 4 generations backK030257 Nobel Perfect Implant SystemNobel Biocare Uas, Inc. · 2003
- 3 generations backK033724 Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc. · 2004
- 2 generations backK040573 Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc. · 2004
- 1 generation backK050444 Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
- This deviceK063592 Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS…Nobel Biocare AB · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962845 | Replace HA Coated Implants | Steri-Oss, Inc. | 1996 | — |
| −5 | K021584 | Replace Scalloped Margin Implant System | Nobel Biocare Uas, Inc. | 2002 | — |
| −4 | K030257 | Nobel Perfect Implant System | Nobel Biocare Uas, Inc. | 2003 | — |
| −3 | K033724 | Nobel Biocare Centric Post, Models 31234, 31235 and 31236 | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K040573 | Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236 | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050444 | Nobelreplace Adapter, Model 32412 | Nobel Biocare Uas, Inc. | 2005 | — |
| 0 (this device) | K063592 | Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP… | Nobel Biocare AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K031719 | Esthetic Zirconia AbutmentSummary page 1…ntal Implant Abutment (21 CFR 872.3630) Trade or Proprietary or Model Narne: Adapter PS Legally Marketed Device(s): Esthetic Zirconia Abutment (K031719) NobelReplace Adapter (K050444) Device Description: Nobel Biocare's Adapter PS is an implant/abutme… | 2003 |
| * | K050444 | Nobelreplace Adapter, Model 32412Summary page 1…or Model Narne: Adapter PS Legally Marketed Device(s): Esthetic Zirconia Abutment (K031719) NobelReplace Adapter (K050444) Device Description: Nobel Biocare's Adapter PS is an implant/abutment system adapter. The Adapter PS allows a Nobel Biocare int… | 2005 |
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 11 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 8 ancestors has a recall.
- 8 other devices also cite its predicate K031719.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063592: Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553, Abutment Screw PS WP-RP, 34554.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063592
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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