510(k) · Cleared
Recalled · Class II · 2019Procera Preparable Abutment System
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 Jan 23, 1998 as substantially equivalent to K971706 (Nobel Biocare Uas, Inc., 1997) after an 80-day review. Its family tree reaches back 4 generations to 1995. 543 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 23, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944964 (1995). 19 ancestors in all, the oldest K910611 (1991). 543 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 3 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 2 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 1 generation backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- This deviceK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998
- Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- Descendant · cites it directly · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 3 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- Descendant · 2 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
Showing 5 of 543 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 543 · See all- K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
- K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · cites it directly441descendants
- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
- K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 3 generations on313descendants
- K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 2 generations on278descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −3 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −2 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −1 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| 0 (this device) | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | — |
| +1 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| +1 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| +2 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +3 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| +2 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 14 | 0 |
| 2010 | 9 | 0 |
| 2011 | 14 | 0 |
| 2012 | 14 | 0 |
| 2013 | 15 | 0 |
| 2014 | 21 | 0 |
| 2015 | 27 | 0 |
| 2016 | 33 | 0 |
| 2017 | 26 | 0 |
| 2018 | 27 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 39 | 0 |
| 2022 | 37 | 0 |
| 2023 | 45 | 0 |
| 2024 | 60 | 0 |
| 2025 | 43 | 0 |
| 2026 | 26 | 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? (1)
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 |
|---|---|---|---|
| * | K971706 | Tiadapt Abutment SystemSummary page 1…The Predicate Product The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare which include the TiAdapt Abutments (K971706). However, the following devices are existing products that have been “cleared” for their indicated use under 510K #971706 for Ti… | 1997 |
What descends from it? (543)
See all 5435 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | 2004 | 476 |
| K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | 2004 | 441 |
| K041655 | Bio Plant System (Implants and Abutments) | 2004 | 91 |
| K034035 | 3I Patient-Specific Overdenture Bar | 2004 | 15 |
| K051501 | Zirace | 2005 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2019 | Class II | Z-1853-2020 | Process control | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. |
| Aug 9, 2019 | Class II | Z-1852-2020 | Process control | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K032263 (Implant Innovations, Inc., 2004) has gone furthest, with 476 descendants of its own.
- 4 other devices also cite its predicate K971706.
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 Procera Abutment System is a set of screw retained preparable abutments
which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic
devices, such as artificial teeth, may be attached using dental cement to restore a patient’s chewing
function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974150: Procera Preparable Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974150
Report an extraction error
Are you the manufacturer?
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